Posted:7 hours ago|
Platform:
Hybrid
Full Time
- 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.
- 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.
Sun Pharma
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