Executive – Regulatory Affairs Position | Sun Pharma Careers
Looking for an exciting Executive – Regulatory Affairs opportunity or a rewarding Chemistry / Pharmaceutical Job? Sun Pharmaceutical Industries Ltd., Baroda, invites talented professionals to join its R&D team. This role provides hands-on experience in regulatory submissions, lifecycle management, and compliance for MENA markets. As part of Sun Pharma Careers, you will grow in a collaborative, innovation-driven environment and contribute to global healthcare solutions.
About Sun Pharmaceutical Industries Ltd.
Sun Pharma is a global leader in pharmaceuticals, dedicated to helping professionals “Create your own sunshine.” The company fosters an environment where employees grow at every step, take charge of their journey, and thrive in a collaborative and supportive community. Through Sun Pharma Careers, employees are encouraged to be “Better every day,” demonstrate self-drive, and work together to achieve excellence.
Job Detail
- Job Post: Executive – Regulatory Affairs
- Location: Baroda, India (Tandalja – R&D)
- Educational Qualification: Graduate (M.Sc. / M.Pharm)
- Experience: 1–4 years in regulatory affairs or pharmaceutical submissions
Job Summary
As an Executive – Regulatory Affairs, you will manage regulatory submissions, renewals, variations, and responses to queries for MENA markets. You will prepare high-quality dossiers, ensure timely approvals, and maintain lifecycle management of drug formulations, supporting regulatory compliance and central repository updates.
Key Responsibilities
1. New Submissions / Renewals:
- Review and prepare CMC (Chemistry, Manufacturing, and Controls) dossiers for new product submissions.
- Review development reports, scale-up reports, specifications, stability protocols, and artworks before exhibit batches.
2. Approval: Prepare and review responses to regulatory deficiencies to enable product approvals.
3. Lifecycle Management: Prepare and review variations as per country-specific requirements, supporting changes such as API vendor updates, formulation site changes, and product harmonization.
4. Regulatory Compliance:
- Circulate approval packages and product history sheets to stakeholders upon receipt of approvals.
- Update central repositories with comprehensive product information and assess the regulatory impact of variations or change controls.
5. Geographic Scope / Market: MENA-GCC region, including UAE, Oman, Saudi Arabia, Egypt, Iran, Iraq, Bahrain, and other countries.
Why Join Sun Pharma Careers
Joining Sun Pharma Careers will offers professional growth in a global pharmaceutical leader. You will gain exposure to international regulatory frameworks, hands-on experience in drug lifecycle management, and opportunities to collaborate with cross-functional teams. Sun Pharma provides a supportive, innovation-driven environment where employees are encouraged to learn, innovate, and make a lasting impact in healthcare.
