Date PostedFebruary 7, 2023
Experience2 Years, 5 Years
Desired QualificationBachelor Degree
Regulatory Affairs Specialist with also exp. with API
Roles and Responsibilities:
- 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.
- 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 a central repository and to provide information about
regulatory commitments in a timely manner.
- 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 with departmental guidelines.
Qualification: M.Pharma, MS/M.Sc(Science) in Organic Chemistry