Senior Scientist, Global Regulatory Lead

Elanco

Global Regulatory Project Lead guiding the regulatory strategy for veterinary products at Elanco. Collaborating with cross-functional teams and leading submissions to regulatory agencies.

Posted 6/19/2026full-timeRemote • 🇺🇸 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
Serve as the dedicated regulatory subject matter expert on development teams
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
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

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
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyclinical trial submissionregulatory submissionsnegotiations with regulatory agenciesproject-specific regulatory risk assessment

Soft Skills

communicationnegotiationinfluencingtechnical leadership

Certifications

Master’s degree in veterinary medicineMaster’s degree in biologyMaster’s degree in infectious diseasesMaster’s degree in immunologyMaster’s degree in animal science