Sun Pharma Hiring Research Scientist

Sun Pharma is the fourth largest generic pharmaceutical company in the world It is also India's largest and most valuable pharmaceutical enterprise by size and market capitalization. The company provides high quality medicines trusted by customers and patients in over ISO countries and has multiple manufacturing facilities and R&D centers. Our leadership is approachable, recognizes people's passions for growth, gives them a voice and empowers them to make a positive change.

Post : Research Scientist

Job Description
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.
1. New submissions:
a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
b. 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:
a. 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:
a. Prepare, Review and circulate approval package with product history sheet to stake holders upon receipt of approval and update the same based on queries and variations.
b. Ensure reposition of comprehensive product information into central repository

Location : Tandalja (Vadodara)- R&D