Research Scientist - Gurgaon, Gurugram, Haryana, India - Sun Pharmaceutical Industries Ltd
Description
Area Of Responsibility
- To review quality and manufacturing end data for various inhouse 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 and Manufacturing locations in generating data as per the requirements of regulatory agencies.
- 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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