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Specialist, Regulatory Affairs FDF

🏢
Centrient Pharmaceuticals
📍 Gurugram, India
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Location Gurugram
📅
Posted June 06, 2026
🚗
Commute Local Area
🎯
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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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    📍 Location Details

    🌆
    City
    Gurugram
    🗺️
    Country
    India
    🚗
    Commute
    Local Area

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