Manager Regulatory Affairs

22 hours ago


Pune, Maharashtra, India Emcure Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Role: Regulatory Affairs Manager

Job Location: Pune

Exp: 8-14 Years

Qualification: B.Pharm/M.Pharm

Job Responsibilities:

Dossier preparation, Submission, Compilation, Query Response, Variation filling

Responsible for pre and post approval activities.

Handling Europe Market.

Strong knowledge of EU regulatory frameworks and guidelines (e.g., EMA, ICH, eCTD).

Experience with dossier preparation in various formats (CTD/eCTD).

Experience in leading a team

If relevant and interested pls share your cv.



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