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Team Member - Regulatory Respiratory Job in Cipla

Team Member - Regulatory Respiratory

Cipla 4+ weeks ago
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Job Summary The Regulatory Affairs Specialist is responsible for managing the regulatory lifecycle of respiratory products, ensuring compliance with global regulations, and supporting timely product launches and commercialization. This role involves preparing and submitting regulatory dossiers, managing post-approval activities, and collaborating with cross-functional teams to achieve regulatory objectives. Key Responsibilities Regulatory Strategy and Compliance Conduct region-wise regulatory requirements analysis and identify gaps in registered dossiers. Develop and recommend regulatory strategies for product submission to leverage existing data and support development activities. Compile respiratory product dossiers, including relevant registration information, and submit them for approval. Prepare and submit deficiency responses to facilitate timely approvals of respiratory products globally. Product Launches and Commercialization Support on-time launches and ongoing commercialization of respiratory products and devices. Coordinate with cross-functional teams to ensure timely review and submission of required documents. Monitor and manage post-approval life cycle activities, including change controls and regulatory packages. Regulatory Database Management Update and maintain the global registration database for respiratory products. Provide regulatory status updates for respiratory products. Portfolio Management Support portfolio initiatives by identifying leverage products through data evaluation and compliance assessment. Contribute to site transfer initiatives to ensure regulatory compliance. Cross-Functional Collaboration Participate in Control Tower, SAP, CIPDOX, GOOSE, and other relevant meetings on behalf of the respiratory team. Required Qualifications Bachelor's or Master's degree in Pharmacy. 6 years of experience in regulatory filing (compilation, submission, and approval) for respiratory products in US, EU, and international markets. Strong knowledge of drug product development and respiratory products. Competencies Collaboration: Ability to work effectively with cross-functional teams. Innovation: Openness to new ideas and willingness to explore innovative solutions. Accountability: Commitment to delivering results and taking responsibility for actions. Empathy: Understanding and consideration for the needs and perspectives of others. Agility: Adaptability to change and ability to respond quickly to evolving situations. Strong Domain Knowledge: Deep understanding of regulatory requirements, product development, and respiratory products. Job Location Vikhroli, Mumbai, India
Qualification :
Bachelor's or Master's degree in Pharmacy.
Experience Required :

Minimum 6 Years

Vacancy :

2 - 4 Hires

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