Adaptis Pharma is hiring an Assistant Manager – Formulation Regulatory Affairs for our Pune (Work From Office) location. We are looking for a skilled professional with experience in Regulatory Affairs for the USA market.
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Job Details
Position:
Assistant Manager – Formulation Regulatory Affairs
Location:
Pune (Work From Office)
Experience Required:
4 to 6 years in Formulation Regulatory Affairs for the USA market
Educational Qualification:
- M. Pharm / B. Pharm
Job Description
- Preparation of ANDA/NDA for Solid Orals/Injectables
- Writing of required sections of M1, M2, M3, and M5
- Review of CMC, Labelling, and Bioequivalence documents for submission
- eCTD compilation
- Review of Original ANDA
- Drafting query responses during the ANDA review cycle
- Post-Approval Supplements support
How to Apply?
Interested candidates can send their CV to:
📧 info@adaptisls.com
