Jamp Pharma Job Vacancy For Regulatory Affairs (Biosimilars)
DEPARTMENT: REGULATORY AFFAIRS
Position: Assistant Manager / Deputy Manager
Experience: 6 - 10 years
Qualification: M.Pharm / M.Sc
Location: Ahmedabad
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.
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.
Send profile at sjani@jamppharma.com
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