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🥝 Senior Manager, Regulatory Affairs (Biologics)
SUN PHARMA | gurugram, India | Posted June 26, 2026
Job Description
JOB DESCRIPTION
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Job Responsibilities
Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.