Looking for a Regulatory Affairs job in Vadodara? A leading pharmaceutical company, Sun Pharmaceutical Industries Ltd., is hiring experienced professionals in Drug Regulatory Affairs for its Vadodara location. This opportunity is ideal for candidates with 1–5 years of experience in regulatory submissions, particularly for MENA markets, and holding an M.Pharm qualification.
This Regulatory Affairs job offers hands-on exposure to dossier preparation, lifecycle management, regulatory submissions, and query responses, making it a strong career move for pharma professionals targeting global regulatory markets.
🔎 Job Overview
- Department: Drug Regulatory Affairs
- Location: Vadodara, Gujarat
- Experience: 1–5 Years
- Qualification: M.Pharm
- Industry: Pharmaceutical / Regulatory Affairs
- Employment Type: Full-Time
📝 Key Responsibilities
As part of the Regulatory Affairs team, the selected candidate will:
- Handle regulatory submission of new products for MENA markets
- Prepare and compile quality dossiers (CTD/eCTD formats)
- Manage post-approval variations and lifecycle management activities
- Draft and submit responses to regulatory queries within defined timelines
- Coordinate cross-functionally with QA, QC, and manufacturing teams
- Ensure compliance with MENA regulatory guidelines and documentation standards
- Track submission timelines to enable timely product approvals
This Regulatory Affairs role focuses on international markets, particularly the Middle East and North Africa (MENA region), offering valuable global regulatory exposure.
🎓 Qualifications & Skills Required
- M.Pharm (Mandatory)
- 1–5 years of experience in Regulatory Affairs (Pharma)
- Experience in MENA market submissions
- Knowledge of CTD, eCTD, ACTD dossier formats
- Understanding of regulatory compliance and variation filing
- Strong documentation and communication skills
Candidates with prior exposure to international regulatory submission processes will have an added advantage.
💼 Why Consider This Regulatory Affairs Job?
- Opportunity to work with a globally recognized pharmaceutical leader
- Exposure to MENA regulatory markets
- Career growth in international drug regulatory affairs
- Hands-on experience in quality dossier preparation and lifecycle management
- Competitive salary structure
💰 Salary (Estimated)
Based on industry benchmarks for Regulatory Affairs professionals in Vadodara:
₹4,50,000 – ₹8,50,000 per annum (CTC)
(Actual salary may vary based on experience and company policy.)
📩 How to Apply
Interested candidates meeting the eligibility criteria can share their updated resume at:
📧 Rosemary.varghese@sunpharma.com