Your Role: Regulatory Affairs Lead - South Asia

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 qualified relationships with health authorities including CDSCO, State FDAs, DAHD, and AQCS.

What You Need to Succeed (minimum qualifications):
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

What will give you a competitive edge (preferred qualifications):
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
Robust 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 rapid-paced environment

Additional Information:

Location: India Mumbai

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manager Ra Bengaluru (India)
🏢 Elanco
📍 India