Regulatory Affairs Executive | Mumbai

• Preparation and Submission of dossiers (CTD, ACTD, NEES, Country specific format including process validation, Product Development report, and Stability data.
• Co-ordination and Collection of Dossier data and samples from plant
• Co-ordination with plant for audit and for specific plant registration.
• Co-ordination for Application of COPP and FSC in plant (P2P and LL) and its follow up.
• Commercial product artwork and MPD checking
• To Handle For Regulatory Affairs For Australia,New Zealand, Canada, Brazil, Mexico, CIS countries , Europe, UK.

Overview

• Industry - PHARMACEUTICAL / MEDICAL DEVICES / CRO
• Functional Area - Legal / Law
• Job Role - Regulatory Affairs - Officer / Executive
• Employment type - Full Time
• Work Mode - In Office

Qualifications

• BSc - Any Specialization, B.Pharma - Any Specialization
• MSc - Any Specialization, MPharma - Any Specialization
• Any Doctorate - Any Specialization

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