Manager RA

Elanco; Bengaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Elanco in India is seeking a Regulatory Affairs Lead to helm registrations and lifecycle management for India and South Asia. You will navigate complex regulatory landscapes to ensure 100% compliance while delivering timely approvals for drugs, biologics, and veterinary products.

With 8+ years in multinational pharma in the veterinary sector, you will oversee PSUR filings and PV activities, coordinate with CDSCO, State FDAs, DAHD and AQCS, and leverage SUGAM and NSWS to optimize submissions.

Qualifications

• Minimum 8 years of focused regulatory experience within a multinational pharmaceutical company, specifically in Veterinary/Animal Health.
• Advanced proficiency in regulatory portals (SUGAM, NSWS) and thorough knowledge of the Drugs & Cosmetics Act and CDSCO guidelines.
• Experience building relationships with health authorities and managing registrations end-to-end.

Responsibilities

• Lead end-to-end registration for new drugs, biologics and pharmaceuticals across India and South Asian markets.
• Compile and review high-quality CMC data to meet registration standards.
• Drive efficiency via SUGAM and NSWS for seamless submissions and rapid approvals.
• Provide PV stewardship for the region, overseeing PSUR filings and AEPC reporting.
• Build and maintain relationships with CDSCO, State FDAs, DAHD, and AQCS.

Skills

Regulatory affairs leadership

SUGAM

NSWS

CDSCO guidelines

Stakeholder management

Education

BVSc & AH, B. Pharm / M. Pharm, or M.Sc in Life Sciences

Tools

SUGAM

NSWS

Drugs & Cosmetics Act knowledge

Job description

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 professional 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
• 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

Location: India Mumbai

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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