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Regulatory Affairs Manager
1 month ago
Organisation :
USV, a top -15 pharmaceutical company in India, excels in the diabetes and cardio sectors. With a presence in over 65 countries, our dynamic team of over 7,000 spans generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase and more.
Responsibilities:
- For the CMC RA position: Biosimilar Product Development Regulatory support – CMC
- For the Clinical RA position Biosimilar Product Development Regulatory support - Clinical
- Biosimilar Regulated market submissions - US / EU or US injectable market submission
- Experience
- Hands on experience in eCTD submissions
- RA support for Plant related QMS activities
Education: M Pharm / B Pharm / M.Sc.
Experience: 4 – 6 years
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