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Regulatory Affairs Consultant

Parexel
Full-time Mumbai, Maharashtra Other-General
Posted:
March 04, 2026
Location:
Mumbai, Maharashtra, India

Job Description

When our values align, there's no limit to what we can achieve.
 

  • 6+ years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
  • Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
  • Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
  • Stron...

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    Job Overview

    Job Type: Full-time
    Location: Mumbai, India
    Posted: March 04, 2026
    Deadline: April 13, 2026