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Assistant Manager - Manager - Regulatory Affairs - API - Formulation

Assistant Manager - Manager - Regulatory Affairs - API - Formulation

Perfect Placement Bureau

7 - 12 years

7 - 15 Lacs

vapi ahmedabad ankleshwar

Posted:None| Platform:

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Skills Required

dossier preparation audit compliance regulatory affairs regulatory compliance client handling regulatory guidelines regulatory audits europe bulk drug regulatory reports dossier compilation mhra eugmp regulatory submissions tga usfda pharmaceutical formulation api who

Work Mode

Work from Office

Job Type

Full Time

Job Description

Expertise in API / Formulation regulatory compliance across EU/ROW regions
Sound knowledge of Drug Substance control strategiesFamiliarity with global regulations: ICH, FDA, EMA, USFDA etcSkilled in responding to Ministry of Health (MoH) queries

Required Candidate profile

M. Pharma / B. Pharma / M.Sc / B.Sc with 7 to 15 Years ExperienceDeep Knowledge of Regulatory Affairs Compliance And Procedures Must be able to work independently And Head Team of junior Officers

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Assistant Manager - Manager - Regulatory Affairs - API - Formulation