Senior Executive, Regulatory Affairs

About the role

Regulatory Affairs at Sun Pharma Industries focuses on ensuring product compliance and facilitating market entry across global regions. The Senior Executive drives new product registrations, variation filings, and lifecycle management, coordinating with CRA, ADD, FDD, MSTG, and PMO to meet regulatory requirements. Based in Halol, Gujarat, this role operates on-site with occasional travel for sample procurement and regulatory submissions.

What you’ll do

• Participate in new product registration and re‑registration activities
• Coordinate regulatory requirements with internal teams
• Manage product lifecycle and change control evaluations
• Prepare and review stability protocols and variation documentation
• Track variation filings and approvals
• Facilitate regulatory sample arrangements for ROW markets

What you’ll bring

• 4-10 years regulatory affairs experience
• experience with new product registration and variation filing
• coordination with cross-functional teams such as CRA, ADD, FDD, MSTG, PMO
• knowledge of stability protocols and change control processes
• ability to prepare CPID and approval packages
• experience in product permission procurement

Benefits

• Robust benefits
• Opportunities for personal and professional growth

Education

M. Pharm/ B. Pharm