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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