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!

We are seeking a strategic Regulatory Affairs Lead – Biologics to lead global regulatory strategy for biologics and vaccine programs within Animal Health. This role owns regulatory strategy, health authority engagement, and regulatory execution across biologics development and lifecycle management activities.

The ideal candidate brings strong experience in biologics regulatory affairs, global regulatory strategy, biologics development, and health authority interactions, along with the ability to influence cross-functional teams across R&D, Manufacturing, Quality, and Technical Operations.

Candidates with biologics, vaccine, biotechnology, biopharmaceutical, or pharmaceutical regulatory experience are encouraged to apply. Prior Animal Health experience is valued but not required.

Why This Role Matters

In this role, you will help shape the regulatory path for innovative biologics and vaccine programs supporting Animal Health globally. Your work will directly influence development strategy, regulatory submissions, agency interactions, manufacturing decisions, and lifecycle management activities across global biologics programs.

This is a highly visible role with broad cross-functional collaboration and strategic ownership across complex biologics regulatory initiatives.

What You Will Do

• Lead global regulatory strategy for biologics, vaccines, and biotechnology programs across development and lifecycle management activities

• Serve as the primary Regulatory Affairs lead for health authority interactions with FDA, USDA/CVB, EMA, and other global regulatory agencies

• Drive preparation, review, and execution of global regulatory submissions, agency responses, and regulatory documentation supporting biologics and vaccine programs

• Guide regulatory strategy for biologics manufacturing changes, process development, process validation, tech transfer, and post-approval lifecycle activities

• Partner cross-functionally with R&D, Manufacturing, Technical Operations, Supply Chain, and Quality to align regulatory strategy with program objectives

• Assess regulatory risks and develop mitigation strategies to support successful biologics development programs

• Ensure compliance with global biologics regulatory requirements, including VICH guidance, GMP expectations, and applicable global regulatory standards

• Influence regulatory strategy and decision-making across multiple biologics and large molecule development programs

• Support lifecycle management activities including manufacturing updates, process improvements, regulatory maintenance, and change management activities
  

What You Bring (Required Experience)

• Bachelor’s degree in a scientific discipline required; advanced degree preferred

• 5+ years of Regulatory Affairs experience supporting biologics, biotechnology, vaccines, biopharmaceuticals, or pharmaceutical development programs

• Demonstrated experience supporting global regulatory strategy and regulatory submissions

• Experience interacting with global health authorities, including FDA, EMA, USDA/CVB, or other regulatory agencies

• Strong understanding of biologics development, manufacturing processes, regulatory submissions, and lifecycle management activities

• Experience partnering cross-functionally across Regulatory Affairs, R&D, Manufacturing, Technical Operations, and Quality

• Strong communication, stakeholder management, strategic thinking, and problem-solving capabilities

Preferred Experience

• Experience in Biologics CMC Regulatory Affairs

• Experience supporting CMC development, manufacturing changes, process validation, tech transfer, or post-approval regulatory activities

• Experience in Animal Health, Veterinary Biologics, Veterinary Vaccines, or related biologics development environments

• Knowledge of USDA/CVB, FDA-CVM, EMA, and VICH regulatory requirements

• Experience leading global or multi-regional biologics regulatory programs

• Experience supporting large molecule biologics, vaccines, immunology, or biotechnology products

• Experience operating within matrixed global regulatory and development organizations

You May Be a Strong Fit If You

• Have led regulatory strategy, not just submission execution

• Bring strong biologics regulatory experience and can apply it across complex global programs

• Are comfortable influencing cross-functional teams without direct authority

• Can navigate both strategic regulatory planning and detailed regulatory execution

• Enjoy partnering across R&D, Manufacturing, Quality, Technical Operations, and Regulatory teams

• Are interested in applying your biologics regulatory expertise within Animal Health

Success in This Role

Success in this role means building effective global regulatory strategies, driving high-quality regulatory submissions, influencing strong cross-functional decisions, and helping biologics and vaccine programs advance efficiently through development and lifecycle milestones.

Compensation / Benefits

Compensation will be aligned to experience, level, and internal equity. This role is eligible for annual bonus opportunities and company benefits.

If your background includes biologics regulatory strategy, biologics development, health authority engagement, vaccine or biotechnology regulatory experience, and cross-functional leadership, we encourage you to apply and start the conversation.

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.

Skill Keywords

Regulatory Affairs • Biologics • Global Regulatory Strategy • Regulatory Submissions • Health Authority Interactions • Biotechnology • Vaccines • Biopharmaceuticals • FDA • USDA/CVB • EMA • VICH • GMP • Lifecycle Management • Process Validation • Manufacturing Changes • Tech Transfer • Large Molecule Development • Cross-Functional Leadership • Animal Health • Veterinary Biologics • Global Regulatory Affairs

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.