Regulatory Affairs Manager - Oncology

Dr. Reddy's Laboratories is a leading global pharmaceutical company committed to providing affordable and innovative medicines. With a strong presence in global markets and a robust portfolio of generic and biosimilar products, the company operates in over 60 countries. Dr. Reddy's is recognized for its excellence in complex generics, oncology, and specialty products with world-class R&D capabilities.

The Regulatory Affairs Manager will lead regulatory submissions and approvals for oncology products across multiple global markets including US, EU, and emerging markets. This critical role requires deep expertise in regulatory strategy, CTD compilation, and managing health authority interactions. You will be responsible for ensuring timely product approvals while maintaining the highest standards of regulatory compliance.

• Lead end-to-end regulatory submissions for oncology products including ANDAs, DMFs, and CTD dossiers for US and EU markets
• Develop regulatory strategies for product development lifecycle from pre-clinical to post-approval stages
• Manage health authority interactions, respond to queries, and coordinate inspections with FDA, EMA, and other regulatory agencies
• Ensure compliance with global regulatory requirements including ICH guidelines, GMP, and pharmacovigilance regulations
• Collaborate with cross-functional teams including R&D, manufacturing, quality, and marketing for regulatory intelligence
• Monitor regulatory landscape, track guideline changes, and provide strategic inputs for business decisions

• 9-12 years of experience in pharmaceutical regulatory affairs with focus on oncology or complex generics
• Proven track record of successful ANDA/DMF submissions and approvals from FDA, EMA, or other major regulators
• Strong knowledge of CTD format, eCTD publishing, and regulatory submission portals
• Experience managing regulatory inspections and handling health authority queries
• Excellent understanding of pharmaceutical development, manufacturing, and quality processes
• M.Pharm, M.Sc in Pharmaceutical Sciences, or Life Sciences; RAC certification is an advantage
• Exceptional documentation skills, attention to detail, and ability to work under tight timelines

• Competitive package between ₹20L – ₹28L per annum
• Work on high-impact oncology products that make a difference in global healthcare
• Join a leading pharmaceutical company with world-class R&D infrastructure and global footprint
• Hybrid work model offering flexibility with 3 days work-from-home per week
• Accelerated career path to senior regulatory leadership roles with exposure to international markets

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