Regulatory Affairs
2 days ago
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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