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Posted on 30 Nov, -0001
Overview
- Industry - PHARMACEUTICAL / MEDICAL DEVICES / CRO
- Functional Area - Legal / Law
- Job Role - Regulatory Affairs - Officer / Executive
- Employment type - Full Time
- Work Mode - In Office
Job Description | Role and Responsibilities
- 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.
Candidate Profile | Who Can Apply
- Experience required - above 2 yrs. in ROW market
- No. of vacancy-3 (Mumbai and Baroda location)
Education
- BSc - Any Specialization, B.Pharma - Any Specialization
- MSc - Any Specialization, MPharma - Any Specialization
- Any Doctorate - Any Specialization
Job Related Keywords
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