Manager- Biologics RA-CMC
2 days ago
USV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India.
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Function: Biologics
Position: Deputy Manager/Manager - Regulatory Affairs-CMC
Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))
Desired Qualification: M.Pharm/B.Pharm
Desired Work Experience: 8-15 years
Job Responsibilities:
Biosimilar Regulated market submissions - US / EU market submission. Preffered US FDA .Alternatively candidates having exp in Small molecules and injectables for US.
Biosimilar Product Development Strategy for CMC and Clinical trials
Review of all Dosisier related Quality documents inclusing coordination with Cross functional teams ( R&D, QC/QA and Manufacturing)
Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions
MOH Query response
Biosimilar Product Life Cycle Management
RA support for Plant related QMS activities
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