Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.
Post : Executive - Regulatory Affairs
Job Description
• Development of marketing and promotional plans for products to support the end consumer’s need
1. New submissions / Renewals :
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 updatethe same based on queries and variations.
b. Ensure reposition of comprehensive product information into central repository
c. Review regulatory filing impact of variations, change controls, etc.
5. Geographic Scope/ Market : MENA-GCC, UAE, Oman, Saudi Arabia, Egypt, Iran, Iraq, Bahrain etc.)
Additional Information
Experience : 1-4 years
Qualification : M.Sc / M.Pharm
Location : Baroda
Industry Type : Pharma/ Healthcare/ Clinical research
Business Unit : Regulatory Affairs
End Date : 20th October 2025
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