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Emcure Pharmaceuticals Limited

9 months ago

Executive/ Assistant Manager Regulatory Affairs - Europe

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Company information

Company
Emcure Pharmaceuticals Limited
Location
India, Maharashtra, Pune India
Posted
9 months ago
View all jobs at Emcure Pharmaceuticals Limited

Job description

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 8years…

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