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Senior Manager/Manager/DM/AM/Senior Executive - Regulatory Affairs Shilpa Medicare Limited

5.0 - 10.0 years

10 - 20 Lacs

raichur

Work from Office

1. Senior Manager/Manager - Regulatory Affairs (API - US/EU Focus) Required: 15-20 years (with 5+ in API regulatory leadership) Qualifications: M.Pharm, B.Pharm, or M.Sc. (Chemistry/Organic) Key Responsibilities: Lead API regulatory strategy, including preparation and submission of US DMFs, EU ASMFs/CEPs, and filings for Japan PMDA/KFDA. Oversee team (5-10 members) for pre-approval inspections, audit responses, and post-approval changes/variations. Manage stability programs, OOS/OOT investigations, and QMS compliance per FDA/EMA guidelines. Collaborate with R&D, QA, and manufacturing for regulatory intelligence and gap assessments. Handle agency queries, renewals, and risk assessments for on...

Posted 9 hours ago

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