Assistant Manager
7 days ago
Manager - Biologics Regulatory Affairs (CMC)
Job Location: Govandi (East ), Mumbai (alternate Saturday working)
Desired Qualification: M.Pharm/B.Pharm
Desired Work Experience: 5-10 years
Job Responsibilities:
1. Biosimilar Regulated market submissions - US / EU injectable market submission.
2. Biosimilar Product Development Strategy for CMC and Clinical.
3. Review of all Dosisier related Quality documents including coordination with Cross functional teams ( R&D, QC/QA and Manufacturing).
4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions.
5. MOH Query response.
6. Biosimilar Product Life Cycle Management.
7. RA support for Plant related QMS activities.
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