Regulatory Affairs Manager - Pharma

Dr. Reddy's Laboratories is a leading Indian multinational pharmaceutical company with a presence in global generic and biosimilar markets. With manufacturing facilities across continents and a portfolio spanning multiple therapeutic areas, Dr. Reddy's is committed to making affordable medicines accessible worldwide.

We are seeking a Regulatory Affairs Manager to lead regulatory submissions and approvals for our India formulations business. This role requires deep expertise in CDSCO regulations, drug approval processes, and lifecycle management of pharmaceutical products.

• Lead end-to-end regulatory submissions for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and product variations to CDSCO
• Ensure compliance with Indian pharmaceutical regulations including Drugs and Cosmetics Act, Schedule M, and GMP guidelines
• Coordinate with R&D, manufacturing, quality, and clinical teams to compile comprehensive regulatory dossiers
• Manage post-approval activities including label changes, manufacturing site transfers, and periodic safety update reports
• Serve as primary liaison with CDSCO and state drug control authorities for queries, inspections, and regulatory intelligence
• Monitor regulatory landscape and assess impact of new guidelines on product portfolio and business strategy

• M.Pharm or B.Pharm with 7+ years of regulatory affairs experience in pharmaceutical industry focusing on Indian markets
• In-depth knowledge of CDSCO regulations, drug approval pathways, and pharmaceutical quality standards
• Proven experience managing successful regulatory submissions for formulations including complex generics
• Strong understanding of ICH guidelines, pharmacovigilance, and post-marketing surveillance requirements
• Excellent project management skills with ability to manage multiple submissions simultaneously
• Outstanding written communication skills for preparing regulatory documents and correspondence
• Experience interacting with regulatory authorities and handling regulatory inspections

• Competitive package between ₹14L – ₹19L per annum
• Play a critical role in bringing affordable medicines to Indian patients across therapeutic areas
• Work with a globally respected pharmaceutical company with strong R&D capabilities
• On-site role at our Hyderabad headquarters with access to world-class facilities
• Clear growth path to senior regulatory leadership roles with exposure to global markets

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