Officer - Regulatory Affairs API - Pune

Job Description:

• Qualification: Post-Graduation in Chemistry
• Work Experience: 3 to 5 years
• Area of Activity: Regulatory Affairs API-DMF

Responsibilities:

1. Filing original DMFs, amendments, and annual reports to USFDA, Brazil, Europe, Japan, etc.
2. Filing original ASMFs/CEPs, ASMF updates, and CEP revisions for the European market.
3. Handling the Educe Software system for regulatory submissions to the US and Europe.
4. Coordinating with various departments to arrange necessary data for DMF filings, amendments and quality updates for the US markets
5. Compiling open part DMFs and providing them as needed for customers

Candidates having experience in Regulatory Affairs - API pls share their updated CV.

Note - Position is only for RA API and not for RA Formulation.