Regulatory Affairs Jobs in Sun Pharma: Hiring an Executive at Baroda | Apply Now for M Pharm Jobs
Sun Pharmaceutical Industries Ltd., India’s leading pharmaceutical company, is hiring an Executive – Regulatory Affairs at its R&D Centre in Baroda (Tandalja). This Regulatory Affairs Job role offers an exciting opportunity to handle regulatory submissions, product lifecycle management, and compliance for MENA markets, contributing to Sun Pharma’s mission of improving healthcare worldwide. Candidates looking for M Pharm jobs with 1–4 years of regulatory experience are encouraged to apply.
Job Details:
- Job Title: Executive – Regulatory Affairs
- Location: Tandalja – R&D, Baroda
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G12A
About Sun Pharma Career:
Sun Pharmaceutical Industries Ltd. is one of the world’s largest specialty generic pharmaceutical companies, headquartered in Mumbai, India. Established in 1983, Sun Pharma provides high-quality, affordable medicines trusted by healthcare professionals and patients in over 100 countries worldwide.
With a robust portfolio spanning chronic and acute therapies, Sun Pharma’s business covers formulations, active pharmaceutical ingredients (APIs), and specialty products. The company operates with a strong commitment to innovation, research, and global compliance, supported by cutting-edge R&D centers and manufacturing facilities across the globe.
Sun Pharma’s core philosophy — “Reimagining Healthcare” — reflects its dedication to improving patient lives, ensuring access to safe and effective treatments, and driving sustainable growth through ethical practices. The company’s culture emphasizes learning, collaboration, and leadership, encouraging every employee to “Create their own sunshine” by taking charge of their professional journey.
Educational Qualification:
- Graduate: M.Sc / M.Pharm
- 1–4 years of experience in Regulatory Affairs within the pharmaceutical industry.
Areas of Responsibility for the Regulatory Affairs Role :
1. New Submissions/Renewals:
- Review and prepare CMC (Chemistry, Manufacturing, and Controls) dossiers for new submissions.
- Review supporting documents such as development reports, scale-up reports, specifications, and stability protocols.
- Verify artworks and documentation before initiating exhibit batches.
2. Approval:
-
Review and prepare responses to deficiencies raised by regulatory agencies to enable timely product approval.
3. Lifecycle Management for Drug Formulations:
Prepare and review variations based on country-specific regulations to support approvals for changes such as:
- API vendor changes
- Route of synthesis/test parameter updates
- Drug formulation site changes
- Product harmonization activities
4. Regulatory Compliance:
- Prepare, review, and circulate approval packages with product history sheets to stakeholders upon receipt of approval.
- Update records based on queries and variations.
- Maintain a comprehensive product information repository.
- Review regulatory filing impacts of variations and change controls.
5. Geographic Scope/Markets:
MENA Region – GCC, UAE, Oman, Saudi Arabia, Egypt, Iran, Iraq, Bahrain, etc.
Travel Estimate:
Not Applicable
