Research Scientist Sun Pharma Jobs – Apply Online
Date: Oct 19, 2023
Location: Tandalja – R&D
About Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd is a leading pharmaceutical company dedicated to providing high-quality and affordable medications to patients across the globe. Committed to innovation and research, we strive to make a positive impact on healthcare.
Job Summary
Regulatory submission of new products, variations, response to queries and Life cycle management for Nepal and Myanmar markets through preparation of quality dossiers enabling timely approvals.
Area Of Responsibility
1. New submissions:
- Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
- Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy.
2. Approval:
- Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
3. Lifecycle management for drug formulations:
- Prepare and review variations as per the country specific requirements to support approval of changes such as API vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
4. Regulatory compliance:
- Prepare, Review and circulate approval package with product history sheet to stakeholders upon receipt of approval and update the same based on queries and variations.
Keywords: Research Scientist, regulatory submission, variations, lifecycle management, pharmaceutical company. Research Scientist Sun Pharma Jobs – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
