Manager RA

Elanco; Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Elanco in Mumbai, India seeks a Regulatory Affairs Lead to drive registration and lifecycle management across India and South Asia. You will oversee CMC data, ensure compliance with CDSCO guidelines, and manage PV obligations while coordinating with health authorities.

Ideal candidates have 8+ years in regulatory roles in veterinary/pharma, with hands-on portal experience and strong stakeholder management skills.

Qualifications

• Minimum 8 years of regulatory experience in veterinary/pharma
• Experience with regulatory portals SUGAM and NSWS; strong CDSCO knowledge
• PV stewardship experience and adherence to SOPs

Responsibilities

• Lead end-to-end registration for drugs, biologicals and pharma products across India and South Asia
• Compile and review CMC data to meet international and local standards
• Utilize SUGAM/NSWS to ensure efficient submissions and approvals
• Oversee PV activities including PSURs and AE reporting with SOP compliance
• Build and maintain relationships with health authorities (CDSCO, State FDAs, DAHD, AQCS)

Skills

Regulatory submissions

SUGAM & NSWS

CDSCO guidelines

PV compliance

Stakeholder mgmt

Education

BVSc & AH / B.Pharm / M.Pharm / M.Sc.

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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