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1 USV Manager Job
Manager (CMC)-RA
USV
posted 17d ago
Job Description
Function: Biologics
Position: Regulatory Affairs- CMC
Job Location: Govandi (East ), Mumbai (2nd & 4th Saturday off, 1st, 3rd and 5th Saturday working)
Desired Qualification: M.Pharm/B.Pharm
Desired Work Experience: 8-12 years
Job Responsibilities:
1. Biosimilar Regulated market submissions - US / EU market submission
2. Biosimilar Product Development Strategy for CMC and Clinical
3. Review of all Dosisier related Quality documents inclusing 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
Employment Type: Full Time, Permanent
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Anonymous · Marketing & Communication
in Mumbai
Learning opportunities
Dysfunctional working Questionable culture Absent work life balance
- Salary - Poor
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