Regulatory Affairs Manager

Dr. Reddy's Laboratories is a leading global pharmaceutical company with a presence in over 60 countries, specializing in APIs, generics, biosimilars, and custom pharmaceutical services. With state-of-the-art R&D facilities and manufacturing plants, Dr. Reddy's is committed to providing affordable and innovative medicines. The company focuses on complex generics, specialty therapeutics, and differentiated formulations.

We are seeking an experienced Regulatory Affairs Manager to lead regulatory submissions and product approvals for markets across EMEA and ROW regions. This critical role involves managing the entire regulatory lifecycle from dossier preparation to product registration and post-approval changes. You will work closely with cross-functional teams to ensure timely approvals and compliance with global regulatory requirements.

• Lead regulatory strategy and submissions for generic formulations across EMEA, MENA, and emerging markets
• Prepare, review, and submit dossiers in CTD/eCTD format for marketing authorization applications (MAAs)
• Manage interactions with regulatory authorities including responding to queries, deficiency letters, and GMP inspections
• Ensure compliance with ICH guidelines, EMA regulations, and country-specific regulatory requirements
• Coordinate with R&D, manufacturing, quality assurance, and commercial teams for regulatory intelligence and lifecycle management
• Track regulatory submissions, maintain compliance databases, and provide timely updates to senior management

• 8-12 years of experience in pharmaceutical regulatory affairs with expertise in international submissions (EMEA, ROW preferred)
• Strong knowledge of CTD/eCTD dossier preparation, GMP guidelines, and regulatory submission processes
• Experience managing regulatory approvals for oral solids, injectables, or other dosage forms
• Excellent understanding of ICH guidelines, EMA, MHRA, and WHO regulations
• B.Pharm/M.Pharm or Life Sciences degree; RAC certification is a plus
• Strong project management, analytical, and communication skills
• Proficiency in regulatory publishing tools and document management systems

• Competitive package between ₹17L – ₹23L per annum
• Lead regulatory strategy for a global pharmaceutical company with presence in 60+ countries
• Work on diverse product portfolio including complex generics and biosimilars
• Collaborative work environment with exposure to global regulatory frameworks
• Comprehensive benefits including health insurance, performance bonuses, and professional development opportunities

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