Jamp Pharma hiring for Assistant Manager / Deputy Manager in Regulatory Affairs department
WE ARE HIRING!
REGULATORY AFFAIRS (BIOSIMILARS)
Assistant Manager / Deputy Manager
Key Responsibilities:
- Evaluate proposed post-approval changes for approved biosimilar products by referring to appropriate guidance and regulations.
- Prepare assigned post-approval submissions for biosimilar products, including Notifiable Changes and Level III, as well as submissions for post-approval Pharmacovigilance and Quality activities.
- Prepare responses to Health Canada questions for assigned projects in a timely manner.
- Participate in the preparation of Supplemental New Drug Submissions and New Drug Submissions.
Ensure documentation prepared in scope of assigned projects is accurately presented.
Specifications:
Candidates with exposure in the pharmaceutical industry with biologics, preferably in regulatory affairs for highly regulated markets.
Demonstrated understanding of both CMC and clinical requirements is needed.
Hands-on experience with literature-based submissions (e.g., 505(b)(2), SRTD) is an added advantage.
- Department: Regulatory Affairs (Biosimilars)
- Experience: 6 – 10 years
- Qualification: M.Pharm / M.Sc
- Location: Ahmedabad
Send profile at [email protected]
Register through link: https://docs.google.com/forms/d/e/1FAIpQLSegklID5lKg44CHq7tISZf29eraloQ1tIu_aPS5D36oEm27Mw/viewform
