Research Scientist - Gurgaon, Gurugram, Haryana, India - Sun Pharmaceutical Industries Ltd
Description
Title:
Research Scientist**:
- Date: Feb 13, 2023
- Location: Gurgaon
- R&D
- Company: Sun Pharmaceutical Industries Ltd
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.
More jobs from Sun Pharmaceutical Industries Ltd
-
Officer - Qc
Ankleshwar, India - 5 days ago
-
Officer - Quality Control
Ankleshwar, India - 1 week ago
-
Manufacturing Assistant
Paonta Sahib, India - 3 days ago
-
Manager-1
Mumbai, India - 1 week ago
-
Executive- Warehouse
Mohali, India - 5 days ago
-
Manufacturing Assistant-granulation
Mohali, India - 1 week ago