FDA Regulatory Specialist Jobs in Bengaluru

Senior Regulatory Affairs Specialist Location: Bangalore Company: AliveCor About AliveCor & The Opportunity AliveCor is a pioneer in **over-the-counter medical ECG devices**, dedicated to making heart health accessible. The company s **FDA-cleared medical-grade hardware and software** have enabled millions of heart health measurements, making a life-saving impact. We are seeking a **Senior Regulatory Affairs Specialist** to join our growing team. This is a critical role focused on **shaping regulatory strategy** for innovative mobile health technologies, managing product submissions, and ensuring compliance with international regulatory standards, including **ISO 13485 and FDA** Quality Systems. Role & Responsibilities As a Senior Regulatory Affairs Specialist, you will: Collaborate & Execute Regulatory Strategies: Work with product teams to **develop and execute global regulatory strategies** for registrations in the US, Europe, and other key regions. Manage Regulatory Submissions: Participate in the preparation and review of **global regulatory submissions**, including **510(k), de novo**, and other medical device filings. Support Government Interactions: Serve as the point of contact for regulatory agencies such as the **FDA, EU MDR**, and other international authorities, ensuring timely product approvals and licenses. Global Market Registrations: Drive product **registrations and renewals** for worldwide markets, supporting distributors with compliance documentation. Review & Approve Technical Documents: Assist in reviewing advertising, promotional materials, and technical documentation to ensure **compliance with applicable regulations**. ISO 13485 & FDA Compliance: Help implement and maintain an **ISO 13485 and FDA-compliant Quality Management System (QMS)**. Product Development Support: Collaborate with cross-functional teams (Engineering, Product, Quality) to support regulatory requirements during product development and design changes. Post-Market Compliance: Assist in post-market regulatory actions, including compliance with **reporting requirements and audits**. Requirements & Qualifications Experience & Education Experience: **4+ years in Regulatory Affairs within the medical device industry.** Education: Bachelor s degree in Science, Engineering, Math, or a medical field, or equivalent experience. Regulatory Experience with AI/ML: Experience in regulatory affairs for **software devices with AI/machine learning algorithms (SaMD)**. Core Regulatory Knowledge Global Regulatory Knowledge: Experience with **EU Medical Device Regulations (MDR)** and familiarity with regulatory processes in the US, EU, and Asia-Pacific regions. Regulatory Submissions: Experience preparing **510(k) submissions, pre-submissions, or de novo submissions** for medical devices. Skills Project Management: Ability to manage small projects with a focus on being organized, independent, and results-oriented. Analytical & Communication Skills: Excellent analytical, communication, and team collaboration skills, with a keen **attention to detail**. Preferred Qualifications Advanced Degree: Master s degree or regulatory affairs certifications such as **RAPS** (Regulatory Affairs Professionals Society). International Submissions: Experience in international submissions, especially in Asia-Pacific or LATAM regions. Perks & Benefits Working Model: Hybrid Working Model (Flexibility to work both remotely and in the office). Family Leave: Comprehensive Family Leave policies. Medical Benefits: Above-market family floater medical insurance, including coverage for parents/in-law parents. Office Perks: Complimentary lunch provided at the office and convenient metro connectivity. Qualification : Bachelors degree in Science, Engineering, Math, or a medical field, or equivalent experience

Assistant Risk Modelling Manager Location: Bengaluru Department: Risk & Modelling About OneSavings Bank (OSB) Group OneSavings Bank (OSB) Group is a specialist lending and retail savings group listed on the London Stock Exchange and a member of the FTSE 250. Headquartered in Chatham, Kent, OSB is regulated by the Prudential Regulation Authority and the Financial Conduct Authority. OSB focuses on niche lending markets offering high growth and strong risk-adjusted returns, including: Buy-to-Let and commercial mortgages Residential development finance Specialist residential lending and secured funding lines We operate under trusted brands such as Kent Reliance, CCFS, InterBay Commercial, Prestige Finance, and Heritable Development Finance. Retail savings are primarily sourced through Kent Reliance via branches, online, and postal channels. Our offshore delivery and support operations are handled by OSB India, with offices in Bengaluru and Hyderabad. About OSB India Pvt Ltd OSB India, a wholly owned subsidiary of OSB Group, plays a critical role in delivering operational and customer support services. Since 2004, OSB India has focused on service excellence, process efficiency, and continuous improvement for the group s UK operations. Role Overview As the Assistant Risk Modelling Manager, you will support capital and impairment reporting, provide deep data insights, and contribute to strategic projects. This role involves analysis, stakeholder collaboration, and ensuring regulatory and internal compliance. Key Responsibilities Lead and support monthly IFRS9 impairment and IRB RWA reporting with trend analysis and insights Provide analytics to support collections and help define operational priorities Drive and deliver strategic projects, managing timelines and stakeholders Assist with IFRS9 engine code changes, conduct impact assessments, and challenge trends Identify process and model weaknesses and develop mitigating solutions Produce clear, insightful commentary for credit and audit committees, including regulatory teams Ensure compliance with model execution and operational risk requirements Maintain adherence to Finance, Risk Management, and Data Governance Policies Build strong working relationships with UK stakeholders and capture clear requirements Complete all mandatory compliance training and attestations Experience Required Minimum 7+ years in a related role in retail or mortgage finance Extensive hands-on experience in SAS, SQL, and advanced Excel Proven ability to generate and present detailed analytical and reporting outputs Experience with impairment/capital modelling processes (preferred) Comfortable managing priorities, leading tasks, and collaborating with international teams Technical & Functional Skills Expert in SAS and SQL for data analysis and reporting Working knowledge of IFRS9 (impairment) or IRB (capital) frameworks Understanding of probability/statistics in a financial risk context (preferred) Core Competencies Strong analytical thinking and problem-solving skills Effective communication skills, both written and verbal Ability to deliver clear, actionable reports to senior stakeholders Self-motivated with a proven ability to learn new technical skills and tools This role is an exciting opportunity to work at the intersection of data, risk, and strategy within a dynamic and growing financial group. If you have a strong analytical mindset and are looking to influence real business decisions, we'd love to hear from you.

Senior Operations Analyst (KYC) Location: Bangalore Experience: 5+ Years Company: KredX About KredX Founded in 2015, KredX has evolved into a comprehensive financial solutions ecosystem. We are India's leading integrated supply chain finance provider, holding both RBI s TReDS license and IFSCA s ITFS license one of the few double-licensed entities in the country. Our flagship platforms include: DTX (Domestic Trade Exchange): RBI-licensed TReDS platform enabling MSME financing via invoice discounting. GTX (Global Trade Exchange): IFSCA-licensed platform facilitating cross-border trade finance. CMS (Cash Management Solutions): AI-driven finance automation streamlining financial operations globally. KredX powers businesses of all sizes with innovative, technology-driven financial solutions. Role Overview We are seeking a highly skilled and detail-oriented Senior KYC Analyst to lead the Know Your Customer (KYC) processes within our Operations team at DTX. This role is critical in ensuring full regulatory compliance while maintaining the integrity of our client relationships. You will drive enhancements in our KYC framework, conduct detailed risk assessments, and provide strategic direction on customer due diligence. Key Responsibilities Lead and manage the end-to-end KYC process, including customer identification, verification, risk assessment, and ongoing monitoring. Conduct in-depth investigations of customer backgrounds, transactions, and compliance to identify risks and suspicious activities. Develop, implement, and continuously improve KYC policies and procedures in line with regulatory requirements and industry best practices. Collaborate with compliance, legal, and operations teams to resolve KYC-related issues and streamline processes. Mentor and train junior analysts, fostering a culture of compliance, accuracy, and continuous improvement. Stay abreast of regulatory updates and emerging trends in financial services, adapting KYC strategies proactively. Required Qualifications & Experience Minimum 5 years experience in KYC, AML, or related compliance roles in financial services. At least 3 years experience working within a TReDS framework is preferred. Strong knowledge of KYC regulations, customer due diligence, and risk assessment methodologies. Proven analytical skills to evaluate complex data and generate actionable risk insights. Excellent communication skills, able to clearly present findings to varied stakeholders. Preferred Qualifications Experience using KYC software platforms such as Actimize, Amlify, or similar tools. Professional certifications like CAMS (Certified Anti-Money Laundering Specialist) or CFE (Certified Fraud Examiner). Familiarity with global financial regulations and international compliance adaptation. Technical Skills & Tools Proficiency in data analysis tools including SQL and advanced Excel functions for investigations and reporting. Experience with risk assessment frameworks related to KYC compliance. Understanding of regulatory reporting requirements and compliance tools.

Data Privacy Compliance Specialist Location: Bangalore, India Office About the Team Rubrik s Legal Team is at the heart of our mission to secure the world s data. We provide essential guidance across contract management, intellectual property, employment law, privacy, trade compliance, and litigation. Our team thrives on open debate, innovation, and ownership, contributing to building an iconic company. Rubrik is growing rapidly and evolving join us to be unstoppable, together. About the Role Rubrik is looking for a Data Privacy Compliance Specialist to strengthen and manage our global privacy program. The ideal candidate will have hands-on experience with privacy management accountability frameworks (PMAF), compliance auditing, and implementing data protection practices aligned with evolving global regulations. This role requires working collaboratively across procurement, engineering, product management, legal, and information security teams worldwide to maintain compliance and mitigate privacy risks. What You ll Do Conduct internal and coordinate external privacy audits as needed. Assess and monitor privacy compliance of third-party vendors and service providers. Continuously review data handling practices to ensure compliance with internal policies and global regulations. Develop, maintain, and enforce data privacy policies and procedures aligned with legal requirements and business objectives. Maintain detailed documentation to demonstrate compliance and accountability. Manage and update an inventory of personal data processing activities, including data flows and classifications. Oversee cross-border data transfer mechanisms ensuring adherence to applicable privacy laws. Lead internal privacy reviews, supporting engineering and data governance teams with data mapping, documentation, and privacy impact assessments. Collaborate with teams to implement privacy risk mitigation solutions while ensuring regulatory adherence. Develop and deliver privacy training to internal stakeholders to raise awareness and ensure compliance with privacy responsibilities. Experience You ll Need Minimum 3+ years of experience in data privacy compliance, preferably with exposure to Privacy Management Accountability Frameworks (PMAF). Strong knowledge of global data protection regulations such as GDPR, CCPA, CPRA, and relevant industry standards. Proven expertise in data mapping, risk assessments, and conducting privacy audits. Excellent communication and stakeholder engagement skills across diverse teams. Certifications such as CIPP-E, CIPM, CIPT, CISSP preferred; Juris Doctor (JD) is a plus. Skills Required Deep understanding of IT, SaaS, and cloud provider compliance challenges. Solid knowledge of information security principles and best practices. Proficiency with privacy management tools like OneTrust for data mapping and assessment automation. Basic understanding of cookies and marketing technology systems. Ability to clearly articulate complex privacy and security concepts to both technical and non-technical audiences. Join Us in Securing the World's Data Rubrik (NYSE: RBRK) is on a mission to secure the world s data with Zero Trust Data Security . Our platform leverages machine learning to secure enterprise, cloud, and SaaS data, helping organizations ensure data integrity, availability, risk monitoring, and rapid recovery from cyberattacks and operational disruptions.

Operations Finance Specialist Location: Bengaluru, India Company: ShopUp HQ Role Overview We are looking for a detail-oriented and analytical Operations Finance Specialist to support our business operations with robust financial planning, analysis, and cost control. You will work closely with operations, procurement, and senior management teams to drive financial efficiency, ensure accuracy, and enable strategic decision-making. Key Responsibilities Data Collection & Validation: Gather financial data from various business and cross-functional teams. Validate data related to Sales, COGS, Damages, Non-claimable items, Incentives, VAT, AIT, etc. Review and ensure accuracy of financial entries in NetSuite. Post journal entries and oversee approval workflows within financial systems. Audit & Compliance: Manage external audits and prepare audited Financial Statements in compliance with IFRS. Perform intercompany balance reconciliations and VAT input/output reconciliations. Ensure compliance with internal financial policies and regulatory requirements. Financial Reporting & Analysis: Prepare MIS reports including weekly, monthly, and yearly flash reports broken down by Subsidiary, Category, Business Unit, and Entity. Conduct entity-wise ICRRS and trend/variance analysis. Reconcile data between DMS and NetSuite. Match MIS reports with audited Financial Statements per IFRS. Monitor operational costs and analyze variances across departments. Support budgeting, forecasting, and strategic financial planning. Cost Control & Collaboration: Assist in implementing cost-control measures to improve financial efficiency. Collaborate with procurement and factory teams to ensure financial accuracy throughout the supply chain. Perform inventory and production cost analysis to support operational decision-making. Additional Duties: Assist in audits and ensure operational finance record accuracy. Identify financial risks and suggest mitigation strategies. Provide ad-hoc financial support and analysis to management as needed. Qualifications & Experience Educational Requirements: Chartered Accountant (CA), ACCA, or equivalent qualification highly preferred. Bachelor s or Master s degree in Accounting, Finance, or related field. Professional Experience: 2 4 years of experience in operations finance, cost accounting, or related financial roles. Skills & Competencies: Strong analytical, problem-solving, and data validation skills. Proficiency in Excel and financial ERP systems (NetSuite preferred). Good communication and cross-team collaboration abilities. Ability to work effectively in a fast-paced, detail-oriented environment. Qualification : Bachelors or Masters degree in Accounting, Finance, or related field.

Technical Lead-Base Level (CTMS Setup) Location: Bengaluru (100% Home-based role) Job Overview: The Technical Lead will be responsible for developing, populating, and supporting templates related to clinical trial payments in the Clinical Trial Management System (CTMS) and other applicable payment systems. The role includes providing assistance and support to Contract & Centralized Services (CCS), business partners, and stakeholders in the use of CTMS for clinical trial payments. This is a fully remote position. Key Responsibilities: CTMS Payment Support: Support the study team training on CTMS payment processes and maintain data entry completeness for clinical trial payments. Issue Resolution & Tracking: Assist with complex issue resolution, resolve failed payments, track issue statuses, and attend meetings to review ongoing issues. Study Setup & Collaboration: Ensure proper study setup in CTMS, collaborate with business partners and stakeholders to address issues and ensure alignment with study goals. Template Creation & Revision: Create or revise payment templates in the CTMS and ensure their accuracy. Issue Management: Support issue resolution via the SAM tool, participate in team meetings, and provide support to other CCS CTMS regions. Adherence to Guidelines: Ensure that all services provided comply with client SOPs, WIs, policies, local regulatory requirements, and ICH-GCP guidelines. Additional Deliverables: Assist with any additional deliverables as assigned to meet project goals and ensure seamless study operations. Qualifications: Education: Bachelor's degree or equivalent in appropriate scientific or business disciplines. Experience: 2-4 years of experience in the pharmaceutical or clinical research industry, specifically in clinical trial payments, pricing, or budgeting. CTMS Experience: Strong hands-on experience with Clinical Trial Management Systems (CTMS) is a must; familiarity with EDC (Electronic Data Capture) systems is a plus. Communication Skills: Fluent in English, with excellent oral and written communication skills. Compliance Knowledge: Familiarity with healthcare compliance and other relevant regulations (e.g., HIPAA, FCPA, Safe Harbor, etc.). Analytical Skills: Strong analytical abilities and problem-solving skills to address challenges effectively. Cross-Functional Collaboration: Ability to work effectively in cross-functional teams and interact with various levels of the organization. PC & Database Management Skills: Proficiency with MS Office suite and database management tools. Work Style: Self-motivated with the ability to work independently and accomplish substantial tasks with minimal supervision. Virtual Work Experience: Previous experience working in a virtual environment and collaborating remotely. Desired Attributes: Innovative Spirit: Ability to bring forward creative solutions to complex problems. Interpersonal Skills: Strong ability to collaborate and maintain positive working relationships with team members and stakeholders. This position offers an exciting opportunity for an individual with a strong background in CTMS, clinical trial processes, and problem-solving abilities, seeking to work in a dynamic and fully remote environment. If you are a motivated professional with experience in clinical trial management and payments, we encourage you to apply. Qualification : Bachelor's degree or equivalent in appropriate scientific or business disciplines.

Job Description: Underground Cable Designer Transmission & Distribution Description: Experience in Design of Underground Power line projects using different software or relevant such as Civil 3D, MicroStation, ArcGIS. Role and Responsibilities: Prepare designs and drawings to be carried out in accordance with relevant codes of practice, standards, regulatory authorities, and clients' requirements. Coordinate with lower-level drafting personnel. Support their mentorship and technical development. Delegate and oversee workload to lower-level drafting personnel assigned to projects. Perform documented quality reviews of drawing packages adhering to the terms of the quality management system. Provide specialist knowledge input and keep up to date with the latest developments in particular fields. Innovate and identify optimal methods to perform design tasks. Be willing to make the necessary travels to carry out project requirements. Coordinate with project engineering and project management teams to ensure timely and quality deliverables. Perform QA/QC reviews of pulling calculations, alignments, layers, design standards, and construction design packages. Promote the interests of the company, for example through personal contacts, representation in professional groups, contributions at meetings and the publication of material where opportunities arise. Qualifications: Diploma in Electrical/Civil with 3-4 years of experience OR ITI in Electrical/Civil with 6-8 years of experience. Underground experience a plus. Transmission or distribution experience preferred. Proven verbal and written communication and IT (office packages) skills. Track record in finding solutions to complex problems within deadlines. Experience leading a team of engineers and designers. Managing multiple projects, deadlines, and deliverables in parallel. Communicating with multiple teams and stakeholders. Priority management and schedule planning. Knowledge of underground powerlines construction methods a plus. Knowledge regarding easements, right-of-way, and permitting considerations and impacts. Knowledge of creating plan & profile drawings using Civil-3D or MicroStation. Able to handle multiple projects simultaneously and to prioritize work. Knowledge of utility telecommunications, distributed energy resource integration, and advanced distribution technologies a plus. Strong analytical capability. Flexibility to work in different roles for different clients both locally and worldwide. Traveling will be a considerable advantage. Capable of devising new approaches to problems encountered. Qualification : Diploma in Electrical/Civil with 3-4 years of experience OR ITI in Electrical/Civil with 6-8 years of experience.

Job Title: GRC Specialist Location: Bangalore (On-site; full-time) About Locus: At Locus, we are redefining logistics decision-making with deep-tech solutions that drive efficiency, consistency, and transparency across industries like retail and FMCG/CPG. Founded in 2015 by Nishith Rastogi and Geet Garg, Locus has evolved from a women s safety geo-tracking app into a globally recognized logistics optimization platform. Our technology has empowered enterprises such as Unilever and Nestl to execute over a billion deliveries across 30+ countries. Guided by our commitment to innovation and sustainable growth, we transform complex supply chains into strategic growth enablers. Join us at Locus and be part of a team shaping the future of global logistics. Job Overview: About the Role Governance Risk and Compliance Specialist (GRC Specialist) We're looking for a candidate with 2-4 years of relevant experience. Key Responsibilities: Define, implement, and maintain the Information Security Management System (ISMS) and Privacy Information Management System (PIMS). Plan and execute periodic risk assessments. Work directly with the business units to facilitate risk assessment and risk management processes. Define, Review and Maintain the organizational information security policies, processes, procedures and control framework to ensure it is adequate to address the emerging risks due to changing environment, technology and legal requirements. Align customer and internal information security objectives to the ISMS and PIMS. Monitor and fulfill client contractual (MSA) information security and privacy obligations. Monitor and fulfill legal obligations related to protection of personal information across different jurisdictions like GDPR, CCPA. Prepare metrics based periodic reports and dashboards with support from the stakeholder functions for management review. Liaise with security vendors, suppliers, service providers and external resources for new security tools for improving security. Lead the Information Security audits / assessments / remediation and present key risks to the management. Perform the Third party Risk Assessment of Critical Vendors. Conduct Information Security and Privacy awareness and training programs for the employees as part of their induction and regular awareness. Oversee information security and privacy incident management process for incident reporting, containment, resolution and root cause analysis. Plan and coordinate BCP and DR tests. Setup guidelines for secure coding practices. Recommend security and privacy controls based on people, process and technology approach and industry best practices. Identifying solutions or writing automation scripts for solving regular tasks or optimizing processes. SOC Monitoring Activities such as. Firewall, Vulnerability, Inspector, Guarduty etc. Log Review, Incident Handling & Compliance adherence. Qualifications: Good understanding of information security compliance requirements like ISO27001, SOC2, CSA STAR and Privacy requirements like BS10012 & ISO27701. Good understanding of legal obligations towards protection of personal information across different jurisdictions like GDPR, CCPA, etc. Experience in creating and auditing security and privacy best practices and implementation of security and privacy principles across organization, to meet business goals along with customer and regulatory requirements. Experience implementing security and privacy controls for cloud platforms like AWS, Azure. Experienced in solving Audit and Regulatory Issues. Experience in auditing MDM, SSO solutions, AWS (Cloud Infra), Firewall, WAF, DLP etc. Good at solving information security compliance challenges by recommending solutions and best practices. Join Locus and become part of a visionary team that is redefining logistics through innovation and smart distribution. We provide competitive compensation, comprehensive benefits, and a collaborative environment where your expertise will drive both your growth and that of the organization. Locus is an equal opportunity employer dedicated to creating a diverse and inclusive workplace.

Job Title: Quality Assurance Analyst Location: Bengaluru Qualifications: BE / Bachelor of Pharmacy / Bachelors of Information Technology Experience Required: Minimum 2 Years About Accenture Accenture is a global professional services company with expertise in digital, cloud, and security. With 699,000+ employees in 120+ countries, we provide Strategy & Consulting, Technology & Operations, and Accenture Song services driving transformation through technology and human ingenuity. Visit us at www.accenture.com Role Overview As a Quality Assurance Analyst, you will work within Accenture s Life Sciences R&D vertical, ensuring compliance, validation, and quality assurance for computerized system applications in pharmaceutical and life sciences operations. You will support hospitals, outpatient clinics, hospices, and other healthcare facilities, ensuring adherence to industry regulations such as GAMP Guidance, 21 CFR, and EU Regulations. Key Responsibilities Validation & Compliance: Perform validation efforts for Accenture projects (system implementation, deployment, validation, and decommissioning). Ensure adherence to FDA regulations and industry standards. Documentation & Project Management: Author and coordinate documentation such as: Test scripts/checklists (IQ/OQ/UAT) Requirements Specification Traceability Matrix System Validation Master Plan Final Validation Report Oversee project management of validation efforts. Team Collaboration & Mentorship: Participate in team meetings and knowledge exchange. Mentor junior members of the Validation Team. Strong experience in Information Management System Testing & Validation Knowledge of Life Sciences CSV (Computer System Validation) Understanding of Life Sciences Automation Enablement Familiarity with regulatory requirements (GAMP Guidance, 21 CFR, EU Regulations) Ability to establish strong client relationships Strong problem-solving and workload prioritization skills Adaptability and flexibility in a fast-paced environment Ability to meet deadlines and work under pressure Work with top pharmaceutical and life sciences companies. Gain expertise in healthcare regulatory compliance. Be part of a dynamic and innovative Life Sciences R&D team. Career growth opportunities in a global organization. Shift Requirement: May require rotational shifts. Qualification : BE / Bachelor of Pharmacy / Bachelors of Information Technology

Main Purpose of the Job: The role is key to the Future of Tax transformation project, with a focus on direct tax, indirect tax, withholding tax, and transfer pricing. You will manage tax data, support tax compliance and reporting, ensure the tax control framework is met, and work closely with both global tax teams and external service providers. You'll also drive process improvements and efficiencies, helping Unilever meet regulatory requirements and business objectives. Key Responsibilities: Tax Compliance & Reporting: Compute VAT and WHT, prepare returns for complex countries. Rule-based calculations for CIT tax provision, advance tax, and quarterly reporting. Manage end-to-end tax data, ensuring the accuracy of master and transactional data. Identify discrepancies in tax data and analyze trends. Tax Payments & Controls: Ensure timely tax payments to authorities in line with local regulations. Meet tax-related controls and compliance standards as per Unilever s framework. Collaboration & Support: Work with Global Tax Teams and third-party providers on changes in tax laws and regulations. Provide documentation and data support for audit queries. Archive direct tax-related documents in accordance with ITGC and audit requirements. Provide data clarifications to relevant stakeholders and support tax audits. Continuous Improvement: Recommend best practices for tax processes and suggest improvements to enhance efficiencies. Implement tools and technologies to drive process improvements. Team Leadership: Lead, coach, and develop a team of two tax data specialists. Manage stakeholders across different countries to ensure process alignment. Key Skills and Requirements: Technical Skills: Strong knowledge of accounting, direct/indirect taxes, withholding tax, and transfer pricing. Proficient in SAP (FI module) and Excel. Experience in consolidating information from accounting/ERP systems. Familiarity with Power BI, Tableau, and workflow management tools is a plus. Experience: Qualified accountant with 5-6 years of experience in Accounting (R2R) and/or Direct/Indirect Tax. Experience in tax compliance and reporting, tax audits, and managing large-scale tax data. Experience transitioning activities to a global hub will be an advantage. Soft Skills: Excellent communication skills, both verbal and written. Proactive, solution-oriented, and capable of driving tasks to completion. Strong problem-solving and analytical skills. Ability to lead small teams and manage relationships across various business functions. Self-starter with proven ownership and accountability. Educational Qualifications: Qualified Accountant (CA, CPA, or equivalent) with 5-6 years of relevant experience. Key Interfaces: Global Tax Team Country Tax Team Country Finance Team Outsourced Service Providers (Big 4) Central R2R/P2P/O2C Teams IT Teams

We are excited to announce an opportunity for a talented individual to join Ericsson as a Technology Specialist. This unique role offers the chance to provide technology leadership in sectors that are of strategic importance to our company. You will be instrumental in the development of innovative solutions, components, and products using cutting-edge technology. As a Technology Specialist, you will significantly contribute to the strategic planning to ensure the competitiveness of our product portfolio. This role requires a global nomination and appointment, with further details available . What you will do: - Drive technology leadership, becoming an in-house spokesperson and advisor to senior management. - Contribute to strategic planning and ensure a competitive product portfolio through technical investigations and task force contributions. - Align technology strategies with product and development goals, influencing Ericsson s research activities. - Judge and introduce new technology advances when they become mature and cost-efficient. - Provide in-depth technical solutions for complex problems and drive the innovation process. - Represent the company in relations with customers and educational institutions, and uphold our position as a technology leader. The skills you bring: Qualification: Bachelor's degree in Electrical / Wireless Communication Engineering. Minimum 8 years of experience in project management within a regulatory environment with specialized knowledge in wireless communication technologies, including Bluetooth, Wi-Fi, and GSM (4G and 5G). Strong knowledge of Wireless global regulatory requirements and experience with regulatory submissions. Excellent organizational, analytical, and problem-solving skills. Excellent written and verbal communication skills, including the ability to interact effectively with global functional teams. Outstanding teamwork and collaboration skills. Proficiency in Microsoft Office 365. Qualification : Bachelor's degree in Electrical / Wireless Communication Engineering.

Job Description Job title: Senior Regulatory Specialist Your role: The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. Author 510k submissions, led pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications and lead interactions with regulators/competent authorities throughout review and approval process. Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development. Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across spectrum of product lines. Monitor global regulatory landscapes and guide cross-functional team on implementation of regulation changes. Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory subject matter expert. Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead or participate on process improvement teams to affect changes at a local or cross business unit level. Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance. You're the right fit if: Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience 510(k) experience is preferred. Preferred candidate will have a master s degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience. Will consider applicants Bachelors Degree with demonstrated experience working within Medical Device industry. Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentations and global registrations Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision. Solution and detail oriented, well organized and self-motivated with ability to negotiate with regulators. May require up to 20% travel How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Qualification : Preferred candidate will have a masters degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience.

Job Purpose and Impact The Controls Testing Specialist will lead and execute testing engagements of IT controls within different technology control domains. In this role, you will consult with business relationship managers, project managers and other key stakeholders to ensure a coordinated approach to monitoring effectiveness of control design and implementation across the organization. Key Accountabilities Participate in the development and execution of assurance processes to ensure appropriate process, procedures and controls are adequately designed, implemented or remediated to meet compliance expectations, efficiency, sustainability goals and business objectives. Test the design and operational effectiveness of existing controls and recommend improvements to align with evolving regulatory and business needs. Write reports with identified findings and provide recommendations. Perform testing engagements including closure within the planned timelines. Consult, validate and monitor the implementation of remediation activities as result of testing findings and other identifications of non-compliance. Collaborate with risk analysts across all areas of the business on common risks to achieve optimization and coordination of remediation activities. Maintain and manage assurance documentation and records. Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff. Qualifications MINIMUM QUALIFICATION Bachelor s degree in IT or CA with IT audit experience. Professional certifications such as CISA, CRISC will be a plus. Strong knowledge of regulatory requirements and compliance standards, such as COSO - SOX, SWIFT, NIST, ISO, COBIT and CIS Knowledge and understanding of Technical Security controls at Network, Server and Application layers Excellent report writing and presentation skills PREFERRED PRIOR EXPERIENCES 5+ years of experience in Audits or Controls Testing or Risk assessment services of IT infrastructure, Applications, IT processes, Business Continuity and Governance. Experience in the implementation of risk remediation activities internally and for external stakeholders Hands-on experience in Test of design controls and Test of operating effectiveness review of IT operational controls. Ability to ensure compliance with risk and security or regulatory policies, standards, procedures and guidelines. Ability to define issues, collect data, establish facts and draw valid conclusions. Respond to and assist with consultation for low complexity risk and security matters. Qualification : Bachelors degree in IT or CA with IT audit experience. Professional certifications such as CISA, CRISC will be a plus.

Role Summary As a Senior Consultant and Subject Matter Expert (SME) specialising in the Banking and Financial Services (BFS) Industry in India, we are seeking a distinguished professional with over 15 years of experience to join our team. The successful candidate will be a seasoned expert in BFS operations, possessing extensive knowledge of banking and financial services, combined with a profound understanding of the regulatory landscape in the Indian market. This role is pivotal in steering our organization toward strategic development in the realm of Digital Technologies BFS services. Key Responsibilities Act as a senior SME, providing expert guidance on Banking and Financial Services operations, products, and services within the Indian market. Collaborate seamlessly with cross-functional teams to optimise and enhance business processes. Provide strategic guidance to the team on IT and Digital Technologies Banking and Financial services. Conduct thorough assessments to identify and mitigate risks associated with BFS operations. Conduct in-depth analysis of business operations, processes, and challenges, identifying opportunities for improvement and innovation through interviews, workshops, and data analysis. Engage with senior leadership to offer strategic insights and recommendations. Contribute actively to the development and execution of business plans within the BFS domain. Foster and maintain effective relationships with regulatory bodies, industry associations, and other external stakeholders. Experience working in Banking Enterprise preferably in Retail Banking business. Possess a comprehensive understanding of the BFS sector in India. Exposure to IT services and product development within the BFS landscape. Showcase proven leadership skills with the ability to influence and guide cross-functional teams. Lead and mentor junior Business Analysts, fostering a collaborative and high-performing team environment. Exceptional communication and interpersonal skills, influencing stakeholders at all levels and building strong relationships. Proficiency in relevant tools and technologies, including Visio, UML, MS Office Suite, data analysis tools, and project management software. Excellent analytical and problem-solving skills with the ability to translate business needs into technical specifications. Proven ability to work independently and manage multiple projects concurrently. Familiarity with RBI regulations, SEBI guidelines, and other relevant laws governing the Indian financial services industry (AML, KYC, BSA, SOX, PCI DSS, CFPB, GDPR, SEC, FATF, Basel III) Qualifications Education: Minimum Bachelor's degree in Finance, Business, Law, PGDBF or a related field. Advanced degrees like MBA Finance, MFC, MFM, CFA or relevant certifications are preferred. Skills Desired Preferably having experience in Global BFS domain. Leverage an established network within the Indian BFS sector, including regulatory bodies, industry associations, and peer organizations. Ability to adapt seamlessly to a rapidly changing regulatory environment and evolving industry trends. Demonstrate a track record of thinking creatively and proposing innovative solutions to complex problems. Competencies Desired Technical / Functional: Relevant certifications in the BFS domain, risk management, compliance, or related fields (e.g. CRMA, CISA, CAMS, PRM, CFSA) will be considered a valuable advantage. Relevant BA certifications (e.g., CSPO, CBAP, PMI-PBA) would be an added advantage. Qualification : Minimum Bachelor's degree in Finance, Business, Law, PGDBF or a related field. Advanced degrees like MBA Finance, MFC, MFM, CFA or relevant certifications are preferred.

Job Description: The Technical Specialist will serve as a Subject Matter Expert (SME) for Software License Management using SNOW (ServiceNow). The role involves providing technical support, handling on-call escalations, conducting root cause analysis, and ensuring timely resolution of tickets within the agreed Service Level Agreement (SLA). Additionally, the specialist will work on knowledge base updates, training junior team members, and ensuring that quality standards and company policies are adhered to. Key Responsibilities: Software License Management (SNOW): Act as the SME for SNOW (ServiceNow) in the domain of software license management, ensuring accurate license tracking and compliance. Ticket Resolution & Root Cause Analysis: Independently resolve tickets within the agreed SLA, conduct root cause analysis for recurring issues, and ensure effective solutions. Customer Support: Provide on-call support, ensuring positive customer experiences and high customer satisfaction (CSAT). Address issues through First Call Resolution and minimize rejected resolutions or reopened cases. Knowledge Sharing: Contribute to the knowledge base by updating and managing information, providing training to freshers, and coaching analysts to enhance their skills and understanding of SAM processes. Quality & Compliance: Ensure adherence to quality standards, regulatory requirements, and company policies, maintaining operational integrity and best practices. Escalation Management: Handle escalations effectively and provide expert support for complex issues, ensuring smooth resolution within the defined timelines. Additional Responsibilities: Ensure continuous improvement in Software Asset Management processes. Contribute to process optimizations and improve overall service quality. Act as a resource for junior team members, providing mentorship and guidance. Qualification : Bachelor of Technology

Site Name: Bengaluru Luxor North Tower Posted Date: Dec 16 2024 GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world over 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued and included. Where they can keep growing and look after their wellbeing.So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Key Responsibilities As a Director , R&D Tech Governance Risk and Compliance , you will be responsible for providing management and day to day support to the Senior Director for Governance, Risk & Compliance activities across the assigned business unit ensuring that Tech risks & controls from project inception to support within their business unit are identified, prioritized, effectively managed, and monitored.This role should work within the business unit to ensure Tech follows the required internal and external compliance standards and delivers a reduction in the overall risk profile for our customers. The primary responsibility of this position will be supporting R&D Tech. Additionally, this role will serve as the Bangalore site lead and play an active role in managing site-specific activities and HR related processes for GRC staff based in Bangalore GCC office. This role will provide YOU the opportunity to lead key activities to progress YOUR career. The role encompasses the following responsibilities: Risk and Compliance Consultancy on strategic programs Facilitate and approve Risk & Compliance Assessments Management and monitoring of CAPAs, Risks, Exceptions, ABAC, and Findings Contribute to the facilitation of functional Risk Management and Compliance Boards (RMCB) Partner with Business Quality Assurance teams for GxP compliance Support Internal / External audits including Audit Readiness activities Provide GRC support and oversight during application development and maintenance Software Change Management Oversight for GxP regulated applications Authorize systems releases Lead and motivate team of GRC manager and specialists Risk Management Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting a Business unit, using Risk and Compliance assessments Facilitate risk identification and risk discussions within the business unit, both operational risk, product/project and strategic risk Assist Tech Business Unit management to make risk informed decisions through a comprehensive Risk Dashboard Raise and approve (where necessary) Policy Exceptions and significant Risks through the GSK integrated risk management tool (i.e., Archer). Input into, review and enforce compliance within Tech Policies and Standards as required within Business Unit Ensure emerging risks are identified and escalated appropriately and in a timely manner Support Product owners in the management of their project risks, ensuring risk identification process is embedded and operational Ensure awareness of security incident response process and report suspected security breach Partner with other GRC and Security staff to deliver a continuous training and education program to ensure ongoing awareness on new and updated Policies and Standards within their Business Unit. Governance & Compliance: Contribute to maintenance of the Business Unit delivery and operational frameworks (Activities, deliverables, roles and responsibilities) and ensure alignment to DTMS Monitor deliverable quality, ensure quality standards are being met for products/ projects, programs or operations within their remit, following a risk based approach, according to DTMS, risk and compliance assessments, and local SOPs. Contribute to providing Project Quality assurance oversight depending on the specific project risk profile, including specific assurance reviews as requested by stakeholders Ensure Business Unit activities align with Regulatory requirements and liaise with Business Quality Groups to contribute to the overall GxP validation status of the business facing application systems or services Contribute to ensuring Business Unit is keeping up with regulatory and legal requirements through a pro-active knowledge management program Quality assurance over the system change control within the Business Unit Supporting Product teams to maximize their velocity by right sizing their governance approach Audit Support Contribute to ensuring Business Unit is ready to host external inspections from regulatory bodies (i.e., FDA, EMEA, tax authorities) as well as external and internal auditors. Support management of overall Business Unit inspection readiness activities and CAPAs in liaison with the business Report status on CAPA s to Business Unit RMCB Information Policy Formation Work with the GRC GxP lead/Controls owners and DTMS team to review and approve the policy, standards, procedures, guidance and training for compliance with relevant legislation and GSK Requirements. Support reviews of the information systems for compliance with legislation and specifies any required changes within their Business Unit Support the GRC Director to implement policies, standards and procedures with aligned Tech Business GRC Consulting Support various GRC planned or remediation activities consulting with BU Tech staff to deliver Support implementation of relevant Management monitoring prog...

Job Title: Statistical Programming Associate Director Career Level - E Introduction to role The Statistical Programming Associate Director is accountable for the quality, timely, and efficient delivery of project programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the Programming discipline. As an expert within their own field, you will act as a specialist within cross-functional teams to deliver continuous improvement. Accountabilities Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function Leads implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverables and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Identifies opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences stakeholders by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Qualification : Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent

Quality Manager Location: Bangalore Department: Operations About the Role IRP Systems, at the forefront of **high-performance e-powertrain systems**, is seeking an experienced **Quality Manager** to oversee all quality assurance and control activities in its automotive manufacturing environment. You will be instrumental in ensuring products meet **customer and regulatory standards** while continuously driving improvements in processes, reliability, and customer satisfaction. Key Responsibilities Quality Management System (QMS): Develop, implement, and maintain the QMS according to **IATF 16949**, **ISO 9001**, and customer-specific requirements. Quality Team Leadership: Lead and manage a team of quality engineers, inspectors, and technicians, ensuring adherence to quality standards and consistency. APQP & Core Tools: Manage **Advanced Product Quality Planning (APQP)**, **PPAP**, and **FMEA** activities to integrate quality into every stage of the product lifecycle. Quality Metrics Monitoring: Track and analyze key quality metrics (e.g., **scrap rate, PPM, customer complaints, warranty data**). Drive corrective actions for continuous improvement. Audits: Lead internal and external audits (**IATF, ISO, customer, and supplier audits**), ensuring full compliance with all quality standards. Customer Interface: Serve as the primary point of contact for customers regarding **quality issues** and performance reviews. Supplier Quality Management: Oversee **supplier qualification, audits, and corrective actions** to ensure quality consistency throughout the supply chain. Root Cause Analysis & CAPA: Facilitate **root cause analysis** and lead the implementation of **Corrective and Preventive Actions (CAPA)** to resolve issues and prevent recurrence. Continuous Improvement: Promote and lead a culture of continuous improvement using methodologies like **Lean, Six Sigma**, and problem-solving tools (**8D, 5 Whys, PDCA**). Compliance: Ensure compliance with all relevant safety, environmental, and regulatory standards applicable to the automotive industry. Skills and Qualifications Experience & Education Education: Bachelor s degree in Electronics Engineering or related fields. Experience: Minimum of **8 years in a Quality leadership role** within the automotive industry, and at least **10 years of experience in electronics and mechanical manufacturing**. Certifications & Standards Expertise Certifications: **Six Sigma Green/Black Belt certification is required.** Standards Expertise: Extensive knowledge of automotive quality standards (especially **IATF 16949**) and familiarity with **ISO 26262 (Functional Safety)**. Technical & Analytical Skills Quality Tools Proficiency: Expertise in using core quality tools such as **8D, APQP, FMEA, SPC, and MSA**. Manufacturing Knowledge: Familiarity with advanced manufacturing processes and technologies relevant to the automotive industry. Analytical Skills: Strong problem-solving and analytical skills to effectively address and resolve customer quality issues. Impactful Work: Contribute to the development of **high-performance e-powertrain systems**. Career Growth: Be part of a dynamic and rapidly growing company with opportunities for professional development. Competitive Benefits: Competitive compensation, flexible working options, and health coverage. Qualification : Bachelors degree in Electronics Engineering or related fields

Position: Finance Specialist Job Type: Full-Time Location: Bangalore Department: Finance About BlueOptima: BlueOptima s vision is to become the global reference for optimizing the performance of software engineers across all industries. We provide industry-leading objective metrics in software development, empowering large organizations to deliver better software, faster, and at a lower cost using groundbreaking technology. With headquarters in London and offices in Mexico, India, and the USA, we ve consistently doubled our headcount and revenue year over year, with no external investment. Our diverse team of 115+ employees comes from over 34 nationalities and speaks more than 25 languages. We promote an open-minded environment and encourage every individual to create their own success story within this high-performance atmosphere. Job Description: We are looking for a Finance Specialist to join our Finance team in Bangalore. Reporting to the Finance Manager, this role will be a key part of the day-to-day financial operations and accounting of the business. You ll be working closely with the finance team and other departments to ensure the timely and accurate delivery of financial data, as well as helping to evolve our financial processes. Key Responsibilities: Finance Operations Management: Oversee the day-to-day operations of the finance team, including managing Accounts Payable (AP), Accounts Receivable (AR), and payroll across all locations. Accounts Payable & Receivable: Ensure timely and accurate payments of dues and collections from customers. Handle vendor invoicing, reconciliations, and communications. Payroll Management: Take ownership of the payroll process, ensuring timely and accurate processing across all locations. Be the go-to person for payroll-related queries from employees. Cross-Functional Collaboration: Work closely with finance consultants and internal teams across various locations on accounting and compliance topics. Month-End & Year-End Closures: Assist with month-end and year-end closures, ensuring books are closed accurately and on time. Audit Support: Provide assistance during local and group audits, ensuring that all financial documents are accurate and comply with regulations. General Ledger (GL) & Reconciliation: Review and maintain GL accounting, perform balance sheet reconciliations, and conduct variance analysis for cost and revenue items. Process Improvements: Review existing financial processes and provide suggestions for improvements to increase efficiency and effectiveness. Global Finance Projects: Gain exposure to global finance projects, working across functions to enhance learning and development opportunities. Qualifications: Essential Requirements: Education: Bachelor's/Master s in Accounting & Finance (e.g., BCom, MCom, MBA). CA Inter cleared is a plus. Experience: Minimum 3-4 years of experience handling AP, AR, and payroll processes. Accounting Fundamentals: Solid understanding of basic accounting principles and financial processes. Taxation Knowledge: Understanding of taxation concepts, such as GST, TDS, and sales tax/VAT. Technical Skills: Proficient in spreadsheet tools (e.g., Excel) and presentation software (e.g., PowerPoint). Cloud-Based Accounting Tools: Experience with cloud-based accounting tools such as Zoho, Xero, QuickBooks, etc. Multi-Region, Multi-Currency Setup: Experience working in a multi-region, multi-currency environment is a plus. Taxation Experience: Experience reviewing and handling sales tax/VAT for the US/UK is an added advantage. At BlueOptima, you ll have the opportunity to make a significant impact on our financial operations while working in a dynamic and fast-growing global company. You ll gain exposure to cross-functional collaboration, global finance projects, and the chance to continuously develop your skills in a high-performance environment. Qualification : Bachelor's/Masters in Accounting & Finance (e.g., BCom, MCom, MBA)

Medical Review Physician 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks. Key Responsibilities Medical Review & Safety Assessment Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality. Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness. Support triage activities and determine seriousness and relatedness across assigned products. Product & Process Expertise Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases. Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs). Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms. Collaboration & Training Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies. Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge. Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently. Compliance & Quality Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines. Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards. Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary. Candidate Profile Education: MBBS or MD is required. Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs. Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements. Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint). Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team. Be part of a high-impact team contributing to global drug safety. Collaborate across a wide range of therapeutic areas and product portfolios. Develop and grow within a supportive, knowledge-driven work environment. Engage in continuous learning and professional development in a critical area of healthcare. Qualification : MBBS or MD is required