Are you looking to advance your career in Regulatory Affairs with one of India’s leading pharmaceutical companies? Sun Pharmaceutical Industries Ltd, a global leader in generic and specialty medicines, is hiring for the role of Executive – Regulatory Affairs at its R&D center in Tandalja, Baroda (Vadodara).
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This is a great opportunity for professionals with 1–4 years of experience in regulatory submissions, lifecycle management, and compliance—particularly for the MENA region (UAE, Oman, Saudi Arabia, Egypt, Iraq, Bahrain, Iran).
Key Responsibilities
As an Executive – Regulatory Affairs at Sun Pharma, you will be responsible for:
- New Submissions & Renewals:
- Review and prepare CMC (Chemistry, Manufacturing, and Controls) dossiers.
- Verify development reports, scale-up reports, specifications, and stability protocols.
- Ensure adequacy of artworks and exhibit batch documentation.
- Regulatory Approvals:
- Draft and review responses to regulatory deficiencies.
- Enable timely approval of submitted products.
- Lifecycle Management:
- Prepare and review variations for country-specific requirements.
- Support changes such as API vendor updates, site transfers, test parameters, and harmonization.
- Regulatory Compliance:
- Maintain comprehensive product information in central repositories.
- Ensure compliance with regulatory filing impacts of variations and change controls.
- Geographic Scope:
- Manage regulatory submissions and approvals across MENA-GCC markets including UAE, Oman, Saudi Arabia, Egypt, Iraq, Iran, and Bahrain.
Qualifications & Experience
- Education: M.Sc. / M.Pharm in Pharmaceutical Sciences or related field.
- Experience: 1–4 years in Regulatory Affairs (pharma industry preferred).
- Skills: Strong knowledge of CMC dossiers, regulatory submissions, and MENA market requirements.
Benefits of Working at Sun Pharma
At Sun Pharma, employees are encouraged to “Create your own sunshine” with opportunities for:
- Professional growth through continuous learning.
- Exposure to global regulatory frameworks.
- Collaborative and supportive work environment.
- Competitive compensation and benefits package.
How to Apply
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