Regulatory Affairs Manager

Dr. Reddy's Laboratories is a leading global pharmaceutical company with a presence in over 100 countries, specializing in active pharmaceutical ingredients, generics, biosimilars, and proprietary products. With robust R&D capabilities and state-of-the-art manufacturing facilities, Dr. Reddy's continues to provide affordable and innovative medicines worldwide.

The Regulatory Affairs Manager will lead regulatory strategy and submissions for pharmaceutical products across US and European markets, ensuring compliance with global regulatory requirements. This critical role requires deep expertise in regulatory pathways, submission management, and cross-functional collaboration with R&D, quality, and business teams.

• Lead regulatory strategy development and lifecycle management for ANDAs, 505(b)(2), and DMF submissions to USFDA
• Prepare, review, and submit regulatory dossiers including CTD/eCTD format for US and EU markets
• Manage regulatory interactions, respond to deficiencies, and coordinate FDA inspections and audits
• Provide regulatory guidance to R&D, manufacturing, and quality teams on CMC requirements and compliance
• Track regulatory intelligence, guideline updates, and competitive landscape to inform strategic decisions
• Build and maintain strong relationships with regulatory authorities and ensure timely approvals

• 8+ years of experience in pharmaceutical regulatory affairs with focus on US FDA submissions
• Hands-on experience with ANDA, 505(b)(2), or NDA submissions and FDA deficiency responses
• Strong understanding of FDA regulations (21 CFR), ICH guidelines, and cGMP requirements
• Expertise in eCTD publishing tools and regulatory submission software
• Excellent scientific writing, communication, and project management skills
• M.Pharm or M.Sc in Pharmaceutical Sciences required; regulatory certification is a strong plus
• Prior experience with USFDA inspections and audit management preferred

• Competitive package between ₹17L – ₹23L per annum
• Play a critical role in bringing affordable medicines to global markets
• Work with one of India's most respected pharmaceutical companies with global footprint
• Access to cutting-edge R&D facilities and collaboration with experienced regulatory professionals
• Clear career path to senior regulatory leadership and global regulatory roles

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