Are you looking to build a strong career in Regulatory Affairs in the pharmaceutical industry? Sun Pharmaceutical Industries Ltd., one of India’s leading global pharma companies, is now inviting applications for the role of Executive – Regulatory Affairs at its Baroda R&D location.
This role is ideal for candidates with M.Pharm or M.Sc qualifications and 1–4 years of hands-on experience in CMC dossier preparation, lifecycle management, filing variations, and regulatory submissions for MENA markets.
If you are passionate about regulatory compliance and drug development and want to expand your experience in GCC regulatory frameworks, this could be your next career milestone.
🧪 Key Responsibilities
As a Regulatory Affairs Executive, you will support:
📌 New Submissions & Renewals
- Review and prepare CMC dossiers for MENA regulatory agencies.
- Assess scale-up, stability protocols, product labels, specifications, and other documents before Exhibit batch initiation.
📌 Regulatory Approvals
- Prepare and respond to deficiency letters and agency queries to ensure timely approvals.
📌 Lifecycle Management
- Prepare and review variations such as:
- API vendor changes
- Test method updates
- Manufacturing site transfers
- Harmonization activities
📌 Regulatory Compliance
- Maintain product history sheets and approval databases.
- Ensure regulatory impact assessment for change controls and variation planning.
- Maintain centralized document repository updates.
🌍 Market Exposure
MENA region: Saudi Arabia, UAE, Oman, Egypt, Bahrain, Iraq, Iran, Qatar, Kuwait and GCC authorities.
🎓 Eligibility & Requirements
| Requirement | Details |
|---|---|
| Education | M.Pharm / M.Sc (Pharmaceutical Sciences, Regulatory Affairs preferred) |
| Experience | 1–4 years in Regulatory Affairs |
| Core Skills | Dossier authoring, variation submissions, CMC knowledge, regulatory query handling |
💼 Why Join Sun Pharma?
Sun Pharma fosters a culture of growth, learning, and teamwork.
Employees receive:
- Career progression & internal mobility opportunities
- Exposure to global regulatory markets
- Access to mentorship and learning programs
- Work-life balance and employee wellness initiatives
📝 How to Apply
