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Sun Pharmaceutical Industries Ltd, India’s largest pharmaceutical company, is hiring an Executive – Regulatory Affairs for its R&D1 Regulatory Affairs division at Tandalja, Baroda. This opportunity is ideal for regulatory professionals with 1–4 years of experience who want hands-on exposure to MENA regulatory submissions, lifecycle management, and CMC documentation.
At Sun Pharma, employees are encouraged to Create Your Own Sunshine—by growing professionally, taking ownership, and thriving in a collaborative environment.
🔍 Job Overview
- Job Title: Executive – Regulatory Affairs
- Job Grade: G12A
- Business Unit: R&D1 Regulatory Affairs
- Location: Baroda, Gujarat
- Markets: MENA (GCC, UAE, Saudi Arabia, Egypt, Iran, Iraq, Bahrain, Oman)
- Experience Required: 1–4 years
- Education: M.Sc / M.Pharm
🧾 Key Responsibilities – Regulatory Affairs (MENA Markets)
1. New Submissions & Renewals
- Review and prepare CMC dossiers for new product registrations.
- Review development reports, scale-up reports, specifications, stability protocols, and artworks prior to exhibit batch initiation.
2. Regulatory Approvals
- Prepare and review deficiency responses to regulatory authority queries to ensure timely approvals.
3. Lifecycle Management (LCM)
- Handle post-approval variations as per country-specific MENA requirements.
- Manage changes related to API vendors, ROS, test parameters, manufacturing sites, and product harmonization.
4. Regulatory Compliance & Documentation
- Prepare and circulate approval packages and product history sheets to stakeholders.
- Maintain accurate regulatory data in the central document repository.
- Assess regulatory impact of change controls and variations.
🎓 Qualifications & Experience
Educational Qualification
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- M.Sc or M.Pharm (mandatory)
Experience
- 1–4 years in Regulatory Affairs, preferably in formulation dossiers and MENA markets
Key Skills
- CMC documentation
- Regulatory submissions & variations
- MENA regulatory guidelines
- Lifecycle management
- Cross-functional coordination
💼 Why Join Sun Pharma?
- Work with India’s No.1 pharmaceutical company
- Exposure to global MENA regulatory markets
- Structured learning and career growth in R&D Regulatory Affairs
- Strong culture of collaboration, ownership, and continuous improvement
- Competitive compensation and long-term career stability
📩 How to Apply
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