Executive Jobs at Sun Pharma | Chemistry Candidates Apply
Are you looking for Executive Jobs in the pharmaceutical regulatory domain with a leading global organization? Sun Pharma Careers brings an exciting opportunity for professionals seeking growth in Regulatory Affairs. This Sun Pharma Jobs opening for an Executive – EM RA role in R&D offers hands-on exposure to regulatory submissions, lifecycle management, and global market coordination, making it an ideal career move for aspiring regulatory professionals.
- Job Title: Executive – Regulatory Affairs
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G12A
- Location: Baroda
About Sun Pharma
Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company and a trusted global leader in specialty generics and innovative medicines. Known for excellence in research, quality, and regulatory compliance, Sun Pharma Careers offers professionals an opportunity to work on impactful projects across regulated and emerging markets. With a strong focus on innovation and employee growth, Sun Pharma Jobs continues to attract top talent across R&D, manufacturing, and regulatory functions worldwide.
Job Description:
Regulatory submission of new products, renewals, variations, response to queries, and life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals.
Area of Responsibility:
- New submissions/Renewals:
- 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.
- Approval:
- Review & prepare response to deficiency, enabling approval of products filed to the regulatory agency.
- 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.
- Regulatory compliance:
- Prepare, review, and circulate the approval package with the product history sheet to stakeholders upon receipt of approval and update the same based on queries and variations.
- Ensure reposition of comprehensive product information into the central repository.
- Review regulatory filing impact of variations, change controls, etc.
Geographic Scope/Market: South Africa, the Middle East, GCC
Travel Estimate: NA
Job Requirements:
Educational Qualification: Graduate: M.Sc /M.Pharm
Experience: Tenure: 1-4 years.
