Sun Pharmaceutical Hiring For Executive Regulatory Affairs

Sun Pharmaceutical Industries Ltd, India’s largest pharmaceutical company and a global leader in specialty generics, is hiring an Executive – Regulatory Affairs (EM RA) for its R&D Regulatory Affairs division at Baroda. This role is ideal for M.Pharm or M.Sc professionals with 1–4 years of Regulatory Affairs experience, particularly in MENA, GCC, and South African markets.

At Sun Pharma, employees are encouraged to “Create their own sunshine” by taking ownership, growing continuously, and thriving together in a collaborative, innovation-driven environment.

📌 Key Responsibilities – Executive Regulatory Affairs

1. New Submissions & Renewals

• Prepare and review CMC dossiers for fresh regulatory submissions.
• Review development reports, scale-up reports, specifications, stability protocols, and artworks.
• Ensure documentation adequacy before initiation of Exhibit batches.

2. Regulatory Approvals

• Prepare and review deficiency responses raised by regulatory authorities.
• Support timely approval of products filed with global health agencies.

3. Lifecycle Management (LCM)

• Handle variations and post-approval changes as per country-specific guidelines.
• Support changes including:
  • API vendor changes
  • ROS/test parameter updates
  • Drug formulation site changes
  • Product harmonization activities

4. Regulatory Compliance

• Prepare and circulate approval packages and product history sheets.
• Maintain and update the central regulatory repository.
• Assess regulatory impact of change controls and variations.

5. Geographic Scope

• South Africa
• Middle East
• GCC countries

🎓 Eligibility Criteria

Educational Qualification

• M.Pharm or M.Sc (Pharmaceutical / Life Sciences)

Experience

• 1 to 4 years of relevant experience in Regulatory Affairs (CMC / Dossier Management)

💼 Why Join Sun Pharma?

• Work with a globally respected pharmaceutical leader
• Strong exposure to international regulatory markets
• Career growth in R&D Regulatory Affairs
• Collaborative and performance-driven work culture
• Competitive compensation and benefits

💰 Salary (Estimated)

₹4,50,000 – ₹8,00,000 per annum (CTC)
(Salary may vary based on experience, skills, and internal policies)

📝 How to Apply

Application Link