Regulatory Affairs Manager - CDSCO & USFDA

Dr. Reddy's Laboratories is a leading Indian multinational pharmaceutical company with a strong presence in generic drugs, active pharmaceutical ingredients (APIs), and biosimilars. With a global footprint across North America, Europe, and emerging markets, Dr. Reddy's is committed to affordable and accessible healthcare.

The Regulatory Affairs Manager will lead regulatory submissions, approvals, and compliance activities for CDSCO (India) and USFDA markets. This critical role ensures timely product launches, regulatory strategy alignment, and adherence to global pharmaceutical regulations.

• Prepare and submit regulatory dossiers (CTD/eCTD) for CDSCO and USFDA product approvals
• Manage lifecycle regulatory activities including variations, renewals, and post-approval changes
• Ensure compliance with CDSCO, USFDA, ICH, and GMP guidelines across product portfolio
• Coordinate with R&D, quality, manufacturing, and commercial teams for regulatory strategy
• Track regulatory timelines, respond to queries, and manage audits and inspections
• Stay updated on evolving regulatory guidelines and provide guidance on compliance

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field
• 8+ years in pharmaceutical regulatory affairs with focus on CDSCO/USFDA submissions
• Strong knowledge of CTD/eCTD formats, ANDA/505(b)(2) pathways, and regulatory strategies
• Hands-on experience with regulatory submission tools and document management systems
• Excellent documentation, communication, and project management skills
• Ability to work cross-functionally and manage multiple projects simultaneously
• Prior experience in formulation development or generic drug filings is a plus

• Competitive package between ₹17L – ₹23L per annum
• Work on regulatory strategy for a global pharma leader with diversified portfolio
• Collaborate with cross-functional teams and international regulatory authorities
• On-site role with stability and long-term career growth in regulatory affairs
• Opportunity to contribute to affordable healthcare and life-saving medicines

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