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Specialist, Regulatory Affairs FDF

📍 Centrient Pharmaceuticals • Gurugram, Haryana, India • Posted June 15, 2026

Full-time Posted June 15, 2026
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Job Description

Description

Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.

Key Individual Accountabilities

  • Collection of information and preparation of dossiers and variation packages as and when required.
  • Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA managers
  • Support in activities related to pharmacovigilance
  • Support in evaluation of CMC data required to support dossiers and variation packages.
  • Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures
  • Creation and updating of product information texts
  • Keepin...

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