Regulatory Affairs Manager

Dr. Reddy's Laboratories is a leading global pharmaceutical company with a presence in over 60 countries. The company is committed to providing affordable and innovative medicines, focusing on chronic therapies, acute treatments, and vaccines.

The Regulatory Affairs Manager will oversee product registration, compliance activities, and regulatory submissions for multiple markets globally. This role is critical to ensuring timely market approvals and maintaining regulatory compliance across the product portfolio.

• Lead regulatory submissions for new drug applications, variations, and renewals across US, EU, and emerging markets
• Develop and execute regulatory strategies to accelerate product approvals and market entry timelines
• Liaise with regulatory agencies including USFDA, EMA, CDSCO, and other health authorities for submissions and inspections
• Ensure compliance with evolving regulatory requirements and implement changes across the product lifecycle
• Coordinate with cross-functional teams including R&D, manufacturing, quality, and commercial for regulatory intelligence
• Manage regulatory documentation, dossier preparation, and response to regulatory queries and deficiencies

• Master's degree or PhD in Pharmacy, Life Sciences, or related discipline
• 8+ years of experience in regulatory affairs within the pharmaceutical industry
• Strong expertise in ANDA, NDA, MAA submissions and regulatory processes for US, EU, and ROW markets
• In-depth knowledge of ICH guidelines, GMP requirements, and global regulatory frameworks
• Proven track record of successful product approvals and managing regulatory inspections
• Excellent project management, communication, and stakeholder engagement skills
• Experience with regulatory information management systems and eCTD submissions

• Competitive package between ₹16L – ₹21L per annum
• Drive regulatory strategy for a diverse portfolio spanning generic and specialty pharmaceuticals
• Work with global regulatory teams and gain exposure to international markets
• Hybrid work model offering flexibility while collaborating with cross-functional teams
• Strong career advancement opportunities within a rapidly growing global pharma organization

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