Regulatory Affairs Manager

Sun Pharmaceutical Industries Ltd. is India's largest pharmaceutical company and the world's fourth-largest specialty generic pharmaceutical company. With a global presence across 100+ countries, Sun Pharma develops, manufactures, and markets a wide range of pharmaceutical formulations and APIs. The company is committed to innovation and making high-quality medicines accessible and affordable.

We are seeking an experienced Regulatory Affairs Manager to lead regulatory submissions and approvals for our domestic and international markets. You will be responsible for ensuring compliance with regulatory requirements, managing USFDA/EMEA submissions, and providing strategic regulatory guidance for new product launches.

• Lead preparation and submission of regulatory dossiers (ANDA, NDA, MAA) to global regulatory authorities including USFDA, EMEA, and CDSCO
• Develop and implement regulatory strategies for new product development and lifecycle management
• Ensure compliance with GMP, GLP, and GCP guidelines across manufacturing sites and clinical operations
• Manage regulatory inspections and audits, coordinate responses to deficiency letters and queries from health authorities
• Provide regulatory intelligence on changing global regulations and assess impact on business operations
• Collaborate with cross-functional teams including R&D, quality, manufacturing, and commercial to align regulatory requirements

• M.Pharm, M.Sc in Pharmaceutical Sciences, or Life Sciences from recognized university
• 8+ years of regulatory affairs experience in pharmaceutical industry with focus on formulations
• Strong knowledge of ICH guidelines, FDA regulations (21 CFR), and global regulatory requirements
• Proven experience in preparing and managing ANDA/505(b)(2)/NDA submissions to USFDA
• Experience in handling regulatory inspections and managing regulatory compliance
• Excellent documentation, communication, and project management skills
• Strong understanding of CMC, bioequivalence studies, and stability requirements

• Competitive package between ₹18L – ₹24L per annum
• Work with India's largest pharmaceutical company on globally impactful regulatory projects
• Gain exposure to diverse therapeutic areas and international regulatory frameworks
• On-site role at corporate headquarters with comprehensive health and wellness benefits
• Clear career progression opportunities in regulatory leadership and international roles

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