Department : Global Regulatory Affairs – Cutting-edge Medicines
Job Responsibilities
- Lead the global regulatory team in the CMC strategy development for established Medicines (Biologics) being developed for US, EU, Canada, Australia, Brazil and RoW markets.
- Coordinate with peers in cross functional team for data driven decision making process for CMC regulatory strategies for established products (Biologics) to be launched for US and other advanced markets like EU, Canada Australia, Brazil, etc.,
- Drive the development projects in collaboration with leads from CFT and project management team towards the regulatory milestones across various geographies
- Mentor the CMC regulatory team in submission management (IND/IMPD, BLA, MAA) and life cycle management of the projects under scope in various markets
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- Represent the regulatory dept in the agency correspondence meetings or scientific advice meetings and guiding the team to prepare for the regulatory meeting packages
- Support new technology development within our Company.
- Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide.
- Conduct all activities with an unwavering focus on compliance.
- Manage the team and be accountable for the deliverables.
Technical Skills:
- Should have handled the successful regulatory submissions for novel biologics / biosimilars for developed markets and Row markets
- Should be able to evaluate the technical information required to build zero defect dossiers of biological products for IND, NDA, BLA and MAA for various markets
📌 DGM-Regulatory Biologics. (India)
🏢 Sun Pharmaceutical
📍 India
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