Regulatory Affairs Specialist – API | Sun Pharma | Gurgaon

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Job Overview

  • Date Posted
    February 7, 2023
  • Location (State / UT)
  • Expiration date
  • Experience
    2 Years, 5 Years
  • Gender
  • Desired Qualification
    Bachelor Degree

Job Description

Regulatory Affairs Specialist with also exp. with API

Roles and Responsibilities:

  • To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.
  • To review outsourced intermediates for regulatory adequacy to support Procurement Team in vendor selection.
  • Coordinate with Chemical Research Department, Analytical Department, and Manufacturing locations in generating data as per the requirements of regulatory agencies.
  • To ensure reposition of API dossiers into a central repository and to provide information about
    regulatory commitments in a timely manner.


  • Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs and ensuring their updation.
  • Preparation of Regulatory Amendments / Variations for smooth API supplies and responses to regulatory deficiencies.
  • Regulatory support to Chemical Research Department, Analytical Department, Chemical manufacturing, Quality Assurance, Procurement Team, and Regulatory Affairs-Pharma.
  • Ensure reposition of regulatory database and compliance with departmental guidelines.

Qualification: M.Pharma, MS/M.Sc(Science) in Organic Chemistry