Regulatory Affairs Manager

Dr. Reddy's Laboratories is a leading global pharmaceutical company with a presence in over 60 countries. Specializing in generic pharmaceuticals, biosimilars, and active pharmaceutical ingredients, Dr. Reddy's is committed to providing affordable and innovative medicines worldwide.

The Regulatory Affairs Manager will lead regulatory submissions and approvals for generic formulations targeting US, EU, and emerging markets. This role requires expertise in ANDA/MAA dossier preparation, regulatory strategy, and managing interactions with global health authorities.

• Lead preparation and submission of ANDAs, MAAs, and DMFs for generic drug products targeting FDA, EMA, and ROW markets
• Develop regulatory strategies for product development lifecycle from pre-submission to post-approval stages
• Manage regulatory responses to deficiency letters, information requests, and health authority queries
• Coordinate with R&D, quality, manufacturing, and business teams for regulatory intelligence and compliance
• Track regulatory timelines, milestones, and ensure on-time submissions aligned with portfolio priorities
• Stay updated on global regulatory guidelines including ICH, USFDA, EMA, and WHO standards

• M.Pharm/M.Sc in Pharmaceutical Sciences with 8+ years in regulatory affairs for generic formulations
• Proven track record of successful ANDA/MAA submissions and approvals from USFDA and EMA
• Strong expertise in CTD/eCTD formats, regulatory publishing tools, and submission gateways
• Deep understanding of ICH guidelines (Q1-Q14), USFDA CFRs, and EU GMP directives
• Excellent project management, documentation, and stakeholder coordination skills
• Strong analytical, problem-solving, and attention to detail capabilities
• Effective communication skills with ability to interact with global regulatory authorities

• Competitive package between ₹17L – ₹24L per annum
• Work with a global pharmaceutical leader on high-impact regulatory projects across markets
• Collaborative work environment with cross-functional exposure and continuous learning
• State-of-the-art facilities in Hyderabad with excellent infrastructure and employee benefits
• Clear career progression to Senior Manager and Associate Director Regulatory Affairs roles

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