Senior Scientist – Global Regulatory Project Lead, Farm Animal

Elanco

Global Regulatory Project Lead at Elanco, guiding regulatory strategy for novel animal health products. Collaborating with global teams and regulatory agencies to ensure successful submissions.

Posted 6/19/2026full-timeIndianapolis • 🇺🇸 United StatesSenior💰 $118,000 - $197,000 per yearWebsite

About the role

Key responsibilities & impact

Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVM/FDA 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 (e.g., CVM, European Medicines Agency (EMA)), including pre-submission meetings and negotiations.
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.

Requirements

What you’ll need

A Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field.
At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary pharmaceuticals.
Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM).
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.

Benefits

Comp & 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

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Hard Skills & Tools

regulatory strategyCVM submissionsFDA submissionsclinical trial submission plansrisk/benefit evaluationsregulatory affairsnegotiations with regulatory agenciesquality frameworkssafety and efficacy evaluationsanimal pharmaceuticals

Soft Skills

communicationnegotiationinfluencingtechnical leadershipcollaborationproject managementproblem-solvingstakeholder engagementrisk identificationstrategic thinking