Elanco Animal Health Expands Mumbai and Bangalore Operations with Opening for Regulatory Affairs Lead

Elanco Animal Health Incorporated, the third-largest animal health company globally and a premier producer of medicines and vaccinations for pets and livestock, has announced a career opportunity for a Regulatory Affairs Lead (Manager RA) based in Mumbai and Bangalore. Originally a subsidiary of Eli Lilly and Company until its divestment in 2019, Elanco continues to pioneer veterinary healthcare solutions worldwide.

Role Overview and Responsibilities

As the Regulatory Affairs Lead, the selected candidate will spearhead registration and lifecycle management across India and South Asia (including Sri Lanka, Bangladesh, and Nepal). Key responsibilities include:

End-to-End Registrations: Lead the registration process for new drugs, biologicals, and pharmaceuticals across regional markets.
CMC & Compliance: Compile and review high-quality Chemistry, Manufacturing, and Controls (CMC) data, ensuring alignment with international and local standards.
Portal Operations: Drive operational efficiency using online regulatory portals such as SUGAM and NSWS for seamless submissions and rapid approvals.
Pharmacovigilance & Stakeholders: Provide regional pharmacovigilance (PV) stewardship—overseeing PSUR filings and AEPC reporting—while building strong relationships with health authorities like CDSCO, State FDAs, DAHD, and AQCS.

Candidate Profile and Qualifications

Education: BVSc & AH, B. Pharm / M. Pharm, or a Master’s degree in Life Sciences.
Experience: Minimum of 8 years of focused regulatory experience within a multinational pharmaceutical company, specifically within the Veterinary or Animal Health sector.
Core Competencies: Advanced proficiency in online regulatory portals (SUGAM, NSWS), expert-level understanding of the Drugs & Cosmetics Act and CDSCO guidelines, and a strong background in artwork/labelling compliance and essential certifications (ML, NCC, GMP, FSC).