Manager RA

Elanco; Mumbai; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Elanco Animal Health Incorporated is seeking a Regulatory Affairs Lead for South Asia, based in Mumbai. You will drive end-to-end registrations for drugs and biologics and oversee lifecycle management across India and neighboring markets.

The role requires strong expertise in regulatory portals (SUGAM, NSWS) and CDSCO guidelines, with PV stewardship responsibilities and close collaboration with health authorities.

Qualifications

• Education in veterinary science or life sciences with regulatory focus.
• Minimum 8 years regulatory experience in animal health/pharmaceuticals.
• Experience in registering drugs/biologics and lifecycle management in South Asia.

Responsibilities

• Lead end-to-end registration for new drugs across India and South Asia.
• Review CMC data to meet international and local standards.
• Manage PV stewardship including PSURs and AE reporting; ensure SOP compliance.

Skills

Regulatory affairs

Regulatory portals

CDSCO guidelines

Pharmacovigilance

Education

BVSc & AH

M.Pharm / MSc Life Sciences

Tools

SUGAM

NSWS

Job description

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

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

Additional Information:

Location: India Mumbai

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for this role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer.

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Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.