Beta Release
2 - 5 Years
Not Disclosed
Full Time
Mumbai (All Areas)

Views:2255

Applicants:39

Posted on 30 Nov, -0001

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)
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 Related Keywords
Education
  • BSc - Any Specialization, B.Pharma - Any Specialization
  • MSc - Any Specialization, MPharma - Any Specialization
  • Any Doctorate - Any Specialization
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