Elanco Animal Health looking for Regulatory Affairs Lead

Elanco Animal Health Incorporated is an American pharmaceutical company which produces medicines and vaccinations for pets and livestock. Until 2019, the company was a subsidiary of Eli Lilly and Company, before being divested. It is the third-largest animal health company in the world.

Post : Manager RA

As a Regulatory Affairs Lead, you will spearhead the registration and lifecycle management of Elanco’s diverse portfolio across India and South Asia. In this role, you will navigate complex regulatory landscapes to ensure our products reach the animals and owners who need them most while maintaining 100% compliance.

Your Responsibilities
• Lead end-to-end registration for new drugs, biologicals, and pharmaceuticals across India and South Asian markets (Sri Lanka, Bangladesh, and Nepal).
• Compile and review high-quality Chemistry, Manufacturing, and Controls (CMC) data, ensuring all registration files meet rigorous international and local standards.
• Drive operational efficiency through expert use of online portals such as SUGAM and NSWS to ensure seamless submissions and rapid approvals.
• Provide critical Pharmacovigilance (PV) stewardship for the region, overseeing PSUR filings and AEPC reporting while maintaining strict SOP compliance.
• Build and maintain strong professional relationships with health authorities including CDSCO, State FDAs, DAHD, and AQCS.

Candidate Profile
• Education : BVSc & AH, B. Pharm / M. Pharm, or M.Sc. in Life Sciences
• Experience : Minimum 8 years of focused regulatory experience within a multinational pharmaceutical company, specifically within the Veterinary/Animal Health sector
• Top skills : Advanced proficiency in regulatory portals (SUGAM, NSWS) and expert-level understanding of the Drugs & Cosmetics Act and CDSCO guidelines
• Master’s degree in Life Sciences or a related field
• Proven ability to translate complex regulatory requirements into actionable business plans for cross-functional teams
• Strong background in managing regional oversight for Sri Lanka, Bangladesh, and Nepal
• Experience in artwork and labelling compliance and coordinating essential certifications (ML, NCC, GMP, FSC)
• Demonstrated proactive leadership with the ability to manage multiple high-priority tasks in a fast-paced environment

Additional Information
Experience : 8 years
Qualification : B. Pharm / M. Pharm, or M.Sc. in Life Sciences
Location : Mumbai, Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September 2026