Regulatory Affairs Manager - Oncology

Dr. Reddy's Laboratories is a leading global pharmaceutical company with a presence across 66 countries, committed to providing affordable and innovative medicines. With a robust portfolio in generics, biosimilars, and complex injectables, Dr. Reddy's has established itself as a trusted healthcare partner worldwide.

The Regulatory Affairs Manager will lead regulatory strategy and submissions for our oncology portfolio across global markets including US, EU, and emerging markets. This critical role ensures compliance with regulatory requirements while accelerating time-to-market for life-saving cancer medications.

• Lead regulatory strategy and lifecycle management for 15+ oncology products across multiple markets
• Prepare and submit regulatory dossiers (ANDA, NDA, MAA) to US FDA, EMA, and other global regulatory agencies
• Coordinate with R&D, manufacturing, and quality teams to ensure CMC compliance and data integrity
• Manage regulatory inspections, audits, and responses to health authority queries
• Monitor global regulatory landscape, guidelines, and policy changes affecting oncology products
• Provide strategic input on product development pipeline and regulatory feasibility assessments

• 10+ years of regulatory affairs experience in pharmaceutical industry with focus on oncology or complex generics
• Strong expertise in ANDA/NDA submissions, CTD/eCTD formats, and global regulatory requirements
• Experience interacting with US FDA, EMA, and other regulatory authorities
• In-depth knowledge of ICH guidelines, GMP regulations, and pharmaceutical quality systems
• B.Pharm/M.Pharm required; additional regulatory certifications (RAC) highly preferred
• Excellent project management, documentation, and cross-functional collaboration skills
• Strong analytical abilities with attention to detail and ability to manage multiple projects simultaneously

• Competitive package between ₹20L – ₹25L per annum
• Lead regulatory strategy for life-saving oncology medications impacting patients globally
• Work with India's leading pharmaceutical research organization with global footprint
• Based at state-of-the-art Hyderabad campus with world-class infrastructure
• Significant exposure to global regulatory agencies and cutting-edge pharmaceutical development

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