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Senior Regulatory Affairs Associate- Biologics

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Parexel
📍 Bengaluru, India
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Location Bengaluru
📅
Posted June 17, 2026
🚗
Commute Local Area
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Job Description

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

Senior Regulatory Affairs Associate (Biologics/Small Molecules)

  • Around 4-6 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
  • Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
  • Experience in handling CMC related health authority queries, and author responses to HA reque...

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    📍 Location Details

    🌆
    City
    Bengaluru
    🗺️
    Country
    India
    🚗
    Commute
    Local Area

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