Senior Scientist – Global Regulatory Project Lead, Farm Animal

Elanco

. Guide the design and development of global regulatory strategy for development projects, primarily focusing on CVM/FDA submissions .

Posted 11/10/2026full-timeRemote • United StatesSenior💰 $118,000 - $197,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in regulatory strategy development for veterinary pharmaceuticals, with a strong focus on CVM/FDA submissions and risk management. Proven ability to lead cross-functional teams and engage with regulatory agencies effectively.

Highest-signal resume keywords

Regulatory Affairs ExperienceCVM/FDA SubmissionsRisk Assessment and ManagementCommunication and Negotiation SkillsGlobal Registration Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRisk/Benefit EvaluationClinical Trial Submission PlanningDirect Regulatory SubmissionsNegotiation with Regulatory AgenciesKnowledge of Continuous Improvement MethodologiesExperience with Farm and Companion Animal ProductsNavigating Novel Regulatory PathwaysGlobal Regulatory ComplianceTechnical Leadership in Regulatory Submissions

Soft Skills

Exceptional Communication SkillsInfluencing SkillsCollaboration with Cross-Functional Teams

Certifications & Qualifications

Master’s Degree or Higher in Veterinary Medicine or Related Field

Industry Keywords

Animal Health IndustryVeterinary PharmaceuticalsU.S. Food and Drug AdministrationEuropean Union Registration ProcessesQuality FrameworksCode of ConductHSE Policies

About the role

Key responsibilities & impact

Guide the design and development of global regulatory strategy for development projects, primarily focusing on CVM/FDA submissions
Serve as the dedicated regulatory subject matter expert on development teams
Provide risk/benefit evaluations to guide project strategy
Lead direct engagements with regulatory agencies, including pre-submission meetings and negotiations
Partner with R&D to develop and implement clinical trial submission plans
Collaborate with internal stakeholders on technical leadership for Quality, Safety, and Efficacy sections of regulatory submissions
Identify and communicate project-specific regulatory risks and opportunities to development teams and leadership
Influence cross-functional partners across R&D, Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services
Comply with company local and global policies

Requirements

What you’ll need

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
Direct regulatory affairs experience in veterinary pharmaceuticals
Demonstrated experience leading direct submissions and negotiations with regulatory agencies
Strong preference for experience with 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
Direct regulatory experience with both farm animal and companion animal products preferred
Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously preferred
Experience navigating novel regulatory pathways for innovative products preferred
Strong understanding of risk assessment and risk management fundamentals preferred
Knowledge of Continuous Improvement methodologies, such as Six Sigma and Lean, preferred
Ability to comply with company local and global policies, including quality frameworks, Code of Conduct, anti-discrimination, harassment, and HSE policies

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
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities