Manager- Biologics RA-Clinical Trials
8 hours 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 (Clinical)
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 Clinical Development Strategy, Clinical trials, injectables
Biosimilar Clinical design and Protocol development, review and finalization
Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization
Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions
MOH Query response
Product Life cycle Management
RA support for Plant related QMS activities
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Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 15,00,000 - ₹ 25,00,000 per yearAbout USV Private Limited:USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.Function: BiologicsPosition: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday...
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