Senior Executive- India Regulatory Affairs

Roles & Responsibilities:
• Evaluate regulatory strategies for product registrations in India
• Coordinate with cross-functional teams to gather all necessary documents for regulatory filings
• Review CMC documents to ensure compliance with regulatory guidelines
• Assess specifications for bulk drugs and formulations as per regulatory expectations
• Review clinical trial and bioequivalence study documents for regulatory submissions
• Conduct literature searches to support application strategies
• Prepare rationale on safety and efficacy of new drugs/FDCs using published literature
• Prepare executive summaries for SEC referrals for drugs not approved in India
• Collect final CMC, CT, and BE documents from cross-functional teams and compile dossiers for submission
• File ND/SND/FDC applications on the SUGAM portal to obtain domestic manufacturing, marketing, or clinical trial permissions
• Review draft specimens, labels, and cartons, and prepare prescribing information referencing international prescribing data

Qualification:
• M.Pharm in Pharmacy, Pharmaceutical Sciences, or related discipline

Experience:
• 8–10 years of experience in regulatory affairs within the pharmaceutical industry, with focus on Indian filings

Skills:
• Strong knowledge of Indian regulatory guidelines and submission processes
• Excellent coordination, documentation, and dossier compilation skills
• Analytical and problem-solving abilities with attention to detail
• Ability to work collaboratively with cross-functional teams and manage multiple submissions

About the Organisation:
Sun Pharmaceutical Industries Ltd. is a global pharmaceutical leader committed to innovation, quality, and patient-centric healthcare solutions. With a robust presence in India and internationally, Sun Pharma provides professionals the opportunity to work on complex regulatory affairs, shape product strategies, and contribute to compliant and timely product registrations.