Global Regulatory Project Lead - Biologicals

US01 Elanco US Inc.; Indianapolis (IN); On-site; USD 118,000 - 197,000; Full time

Benefits offered by this job

Relocation packages

Two shutdowns in US (mid-summer, year‑

PTO

8-week parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401(k) matching

Job summary

Elanco is seeking a Global Regulatory Project Lead - Biologicals to guide regulatory strategy for farm and companion animal products. You will lead global submissions, negotiate with agencies, and coordinate with R&D, QA, and other functions to align on development plans.

This role requires a strategic, communicative leader capable of navigating complex regulatory landscapes. You will interact with US, EU, and first-wave markets, travel 10–25%, and contribute to a high-impact regulatory program

Qualifications

• Master’s degree or higher in veterinary medicine or related field.
• 10+ years in animal health with regulatory affairs experience in veterinary biologics.
• Experience leading submissions and negotiations with regulatory agencies, preferably USDA CVB.

Responsibilities

• Guide global regulatory strategy for development projects focusing on CVB submissions.
• Act as regulatory expert on cross-functional development teams and negotiate with agencies.
• Collaborate with R&D to develop clinical submission plans and ensure alignment with strategy.
• Provide leadership on Quality, Safety, and Efficacy sections for submissions.
• Identify regulatory risks and communicate opportunities to leadership.
• Ensure compliance with company policies and health, safety, and environment guidelines.

Skills

Regulatory leadership

Cross-functional collaboration

Negotiation

Strategic thinking

Education

Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or related field

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!

Company Overview:

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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet, and our enterprise. 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:

Global Regulatory Project Lead - Biologicals As the Global Regulatory Project Lead, you will be a key individual contributor at the forefront of our innovation pipeline, guiding the regulatory strategy for novel farm and companion animal biological products. You will serve as the dedicated regulatory expert on global project teams, shaping development from the ground up and leading direct negotiations with agencies like the USDA’s Center for Veterinary Biologics (CVB). This role requires a strategic professional who can navigate complex agency interactions, influence cross-functional partners (including Global Research and Development (R&D), Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services), and ensure our submissions in the United States (US), European Union (EU), and other first-wave countries are successful.

Your Responsibilities:

• Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVB submissions.
• Serve as the dedicated regulatory subject matter expert on development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
• Act as the primary point of contact for and lead direct engagements with regulatory agencies.
• Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
• Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
• Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership.
• Comply with all company local and global policies including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.

What You Need to Succeed (minimum qualifications):

• Education: A master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field.
• Experience: At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary biologicals.
• Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the USDA – Center of Veterinary Biologics (CVB).
• Guidance & Influence: Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment, with exceptional communication, negotiation, and influencing skills.

What will give you a competitive edge (preferred qualifications):

• Direct USDA-CVB regulatory experience with both farm animal and companion animal products.
• Experience navigating novel regulatory pathways for innovative products.
• Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
• A strong understanding of risk assessment and risk management fundamentals.
• Knowledge of Continuous Improvement methodologies (e.g., Six Sigma, Lean).

Additional Information:

• Travel: 10-25%.

Elanco Benefits and Perks:

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching #LI-SC1

Compensation:

Elanco currently anticipates that the base salary for this position could range from $118,000 to $197,000 depending partly on the successful candidate’s qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees.

Estimated application closing date is (insert date). Applications will be accepted on an ongoing basis.

EEO Statement:

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. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Identity and Mission:

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.