Regulatory Affairs

2 days ago

Gurgaon, Haryana, India Sun Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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 and APIs for regulatory adequacy to support Procurement Team in vendor selection and DF-Regulatory for ANDA/MA submission.

  • To coordinate & support Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies for regulatory submissions as well as for responding regulatory queries.

  • To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner.

Deliverables

  • Compilation and review of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs and ensuring their updation.

  • Preparation and review of Regulatory Amendments / Variations for smooth API supplies

  • Preparation of 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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