Manager, Regulatory Affairs - Cmc Job in Msd

Job Opening: Manager, Regulatory Affairs - CMC

Location: Hyderabad, India | Full-Time

About the Role

The Manager, Regulatory Affairs - CMC, is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products, in accordance with global regulations and defined regulatory strategies. This role will involve preparing and reviewing the necessary information for the development of regulatory CMC dossiers for commercial products.

Our Regulatory Affairs team is dedicated to advancing medical breakthroughs by facilitating communication and procedures that ensure swift, organized compliance across regulatory agencies. As part of our international network, you will play an integral role in ensuring the compliance and approval of medical products, helping to provide reliable healthcare solutions to the world.

Primary Responsibilities

Regulatory Responsibilities:

• Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements.
• Lead the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, variations, annual reports, registration renewals, and responses to health authority questions.
• Liaise with global CMC, Manufacturing Divisions, and external partners to ensure compliant execution of change management.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Ensure timely delivery of all regulatory milestones for assigned products across the product lifecycle.
• Identify and communicate potential regulatory issues to GRACS CMC management as needed.

Technical Skills:

• Review scientific information to assess the technical merits and suitability of scientific rationale, ensuring clarity and support from data.
• Demonstrated ability to communicate issues succinctly and logically, both orally and in writing.
• Solid understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.
• Proficient in operating electronic document-based GMP systems.

Leadership Skills:

• Ability to generate innovative solutions to problems and effectively communicate with key stakeholders.
• Demonstrated flexibility in adapting to changing priorities and dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Effective leadership, communication, and interpersonal skills.

Qualifications & Skills

• Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
• Minimum of 5-7 years of experience in the pharmaceutical industry, with at least 4 years of experience in managing CMC regulatory submissions for small molecules, vaccines, or biologics.
• Ability to travel to other CMO sites on a need basis.

Why Join Us?

• Join a global company that is leading the charge in medical advancements.
• Play a vital role in ensuring compliance and regulatory success for life-changing pharmaceutical products.
• Collaborate with diverse teams to drive innovation and shape the future of healthcare.

Who We Are

We are proud to be a company that embraces diversity and fosters an inclusive environment. At our organization, the fastest breakthroughs come when diverse ideas come together. We encourage our colleagues to challenge each other s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to promoting diversity and inclusion in the workplace.

What We Look For

If you re passionate about regulatory affairs and ready to make a meaningful contribution to the global pharmaceutical landscape, join us. Your expertise will help shape the future of medicine and impact generations to come.