Beta Release

Regulatory Affairs Executive | Mumbai

Rusan Pharma Ltd Follow

  • 2 - 5 years
  • Not Disclosed
  • Mumbai (All Areas) / India

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

Job Related Keywords

  • Functional Area - Legal / Law
  • Industry - PHARMACEUTICAL / MEDICAL DEVICES / CRO
  • Job Role - Regulatory Affairs - Officer / Executive
  • Job Type - Full Time

Education

  • B.Sc - Any Specialization, B.Pharma - Any Specialization
  • M.Sc - Any Specialization, M.Pharma - Any Specialization
  • Any Doctorate - Any Specialization

About Employer

Candidate Can connect

Similar Jobs

Regulatory Affairs Executive | Mumbai

Zenzi Pharmaceutical Industries Pvt.Ltd

  • 2 - 8 years
  • ₹ 250000 - 600000 P.A
  • Mumbai (All Areas), India

Key Skills- Dossier Preparation, Ctd, Row Market, Regulatory Affairs, ACTD, Regulatory Affairs Executive, RA, API, Chemistry, Pharma, HR