Sr Scientist - Global Regulatory Project Lead - Farm Animal
Elanco
August 23, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Global Regulatory Project Lead
Responsibilities:
- Guide design and development of global regulatory strategy for development projects (primary focus: CVM/FDA submissions).
- Serve as regulatory subject matter expert on development teams; provide risk/benefit evaluations to guide strategy.
- Lead direct engagements with regulatory agencies (e.g., CVM, EMA), including pre-submission meetings and negotiations.
- Partner with R&D to develop and implement clinical trial submission plans aligned to overall regulatory strategy.
- Provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities.
- Comply with company quality frameworks, Code of Conduct, anti-discrimination/harassment, and HSE policies.
Qualifications (minimum):
- Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or related field.
- 10+ years relevant animal health industry experience, including veterinary pharmaceutical regulatory affairs.
- Demonstrated experience leading direct submissions and negotiations with regulatory agencies (strong preference: FDA CVM).
- Ability to serve as primary regulatory expert on cross-functional global teams; exceptional communication, negotiation, and influencing skills.
Preferred:
- Direct regulatory experience with both farm animal and companion animal products.
- Experience with global registration processes; leading EU and other first-wave submissions simultaneously.
- Experience navigating novel regulatory pathways for innovative products.
- Risk assessment/risk management fundamentals.
- Continuous improvement knowledge (e.g., Six Sigma, Lean).
Benefits/Perks (highlights in posting):
- Multiple relocation packages; 8-week parental leave; annual bonus; flexible work arrangements; up to 6% 401K matching.
Application instructions:
- Applications accepted on an ongoing basis until the role is filled.
Responsibilities:
- Guide design and development of global regulatory strategy for development projects (primary focus: CVM/FDA submissions).
- Serve as regulatory subject matter expert on development teams; provide risk/benefit evaluations to guide strategy.
- Lead direct engagements with regulatory agencies (e.g., CVM, EMA), including pre-submission meetings and negotiations.
- Partner with R&D to develop and implement clinical trial submission plans aligned to overall regulatory strategy.
- Provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities.
- Comply with company quality frameworks, Code of Conduct, anti-discrimination/harassment, and HSE policies.
Qualifications (minimum):
- Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or related field.
- 10+ years relevant animal health industry experience, including veterinary pharmaceutical regulatory affairs.
- Demonstrated experience leading direct submissions and negotiations with regulatory agencies (strong preference: FDA CVM).
- Ability to serve as primary regulatory expert on cross-functional global teams; exceptional communication, negotiation, and influencing skills.
Preferred:
- Direct regulatory experience with both farm animal and companion animal products.
- Experience with global registration processes; leading EU and other first-wave submissions simultaneously.
- Experience navigating novel regulatory pathways for innovative products.
- Risk assessment/risk management fundamentals.
- Continuous improvement knowledge (e.g., Six Sigma, Lean).
Benefits/Perks (highlights in posting):
- Multiple relocation packages; 8-week parental leave; annual bonus; flexible work arrangements; up to 6% 401K matching.
Application instructions:
- Applications accepted on an ongoing basis until the role is filled.