Research Manager

4 days ago

Gurgaon, Haryana, India Sun Pharmaceutical Industries, Inc. Full time ₹ 15,00,000 - ₹ 25,00,000 per year
Title: Research Manager

Date: Sep 23, 2025

Location: Gurgaon - R&D

Company: Sun Pharmaceutical Industries Ltd

Area Of Responsibility

  • 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.
  • To coordinate with Chemical Research Department, Analytical Department Chemical manufacturing and Quality Assurance, in generating data as per the requirements of regulatory agencies.
  • Regulatory support to Procurement Team and Regulatory Affairs-Pharma
  • Ensure compliance to regulatory & departmental guidelines
  • To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner.

Deliverables

  • 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 to departmental guidelines.

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