Regulatory Affairs Manager

Dr. Reddy's Laboratories is a leading global pharmaceutical company with a presence in over 60 countries. The company focuses on affordable and innovative medicines across therapeutic areas including gastrointestinal, cardiovascular, diabetology, oncology, and pain management. With state-of-the-art manufacturing facilities and robust R&D capabilities, Dr. Reddy's is committed to accelerating access to quality healthcare.

The Regulatory Affairs Manager will lead regulatory submissions and approvals for generic and specialty pharmaceutical products in US and European markets. This strategic role involves managing complex regulatory pathways including ANDA, 505(b)(2), and MAA filings while ensuring compliance with USFDA and EMA guidelines. You will collaborate with cross-functional teams to drive product approvals and maintain regulatory intelligence on evolving compliance landscapes.

• Manage end-to-end regulatory submissions for ANDA and 505(b)(2) applications to USFDA
• Lead preparation and filing of Marketing Authorization Applications (MAA) for European markets
• Coordinate with R&D, Manufacturing, Quality, and Clinical teams to compile comprehensive dossiers
• Respond to regulatory queries and deficiency letters from health authorities within stipulated timelines
• Monitor regulatory guideline updates from USFDA, EMA, and ICH and assess impact on product pipeline
• Provide regulatory strategy inputs for product development and lifecycle management initiatives

• Master's degree in Pharmacy, Pharmaceutical Sciences, or Life Sciences; Ph.D. preferred
• Minimum 8 years in pharmaceutical regulatory affairs with focus on US and EU submissions
• Proven track record of successful ANDA/505(b)(2) approvals and MAA filings
• Deep understanding of CTD/eCTD formats, regulatory submission requirements, and health authority expectations
• Strong knowledge of pharmaceutical development, GMP regulations, and drug approval processes
• Excellent documentation skills and proficiency in regulatory publishing software
• Ability to manage multiple regulatory projects simultaneously under tight timelines

• Competitive package between ₹16L – ₹21L per annum
• Drive regulatory strategy for products that improve global healthcare access
• Work with Dr. Reddy's renowned regulatory team managing one of India's largest product portfolios
• On-site role at Hyderabad headquarters with comprehensive healthcare benefits
• Growth opportunities into Senior Regulatory Leadership and Global Regulatory Strategy roles

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