Executive/ Assistant Manager Regulatory Affairs - Europe

Role: Regulatory Affairs - Executive/ Assistant Manager

Job Location: Ahmedabad

Exp: 5-10 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 having 8+years of experience.