Officer/Executive Regulatory Affairs -API

• 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 good knowledge of US, EU, and Canada regulatory requirements.

Qualification : B.Pharm / M.Pharm / M.Sc.