- Preparation and filing of original DMFs, amendments, and annual reports for USFDA.
- Preparation and submission of ASMFs, ASMF updates, CEP applications/revisions for Europe and regulatory documents for Canada market.
- Handling regulatory submissions through DocuBridge & EDUCE software.
- Maintaining regulatory documentation and ensuring compliance with US, European, and Canadian regulatory requirements*.*
Preferred Skills: Experience in DMF, ASMF, CEP submissions, DocuBridge & EDUCE software, and positive knowledge of US, EU, and Canada regulatory requirements.
Qualification : B.Pharm / M.Pharm / M.Sc.
📌 Officer/Executive Regulatory Affairs -API (Pune)
🏢 Emcure
📍 Pune