Senior Scientist, Global Regulatory Lead
Elanco
August 24, 2026
Remote friendly (United States)
United States
Corporate Functions
Global Regulatory Project Lead
Responsibilities:
- Guide the design and development of global regulatory strategy for development projects (primary focus: CVM/FDA submissions).
- Serve as dedicated 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 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 local/global policies (quality frameworks, Code of Conduct, anti-discrimination/harassment, HSE).
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 regulatory affairs in veterinary pharmaceuticals.
- Demonstrated experience leading direct submissions and negotiations with regulatory agencies (strong preference: FDA CVM).
- Exceptional communication, negotiation, and influencing skills; able to lead as primary regulatory expert on cross-functional global teams.
Preferred:
- Direct regulatory experience with both farm animal and companion animal products.
- Broad global registration experience; leading first-wave EU and other key market submissions concurrently.
- Experience with novel regulatory pathways for innovative products.
- Risk assessment and risk management fundamentals.
- Continuous improvement knowledge (e.g., Six Sigma, Lean).
Benefits & pay (highlights in posting):
- Up to 6% 401K matching; multiple relocation packages; two weeklong shutdowns (mid-summer and year-end, in addition to PTO); 8-week parental leave; annual bonus offering; flexible work arrangements.
- Base salary range: $118,000–$197,000 (dependent on qualifications/education/experience); eligibility for company bonus.
Application instructions:
- Estimated application closing date is (insert date); applications accepted on an ongoing basis.
Responsibilities:
- Guide the design and development of global regulatory strategy for development projects (primary focus: CVM/FDA submissions).
- Serve as dedicated 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 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 local/global policies (quality frameworks, Code of Conduct, anti-discrimination/harassment, HSE).
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 regulatory affairs in veterinary pharmaceuticals.
- Demonstrated experience leading direct submissions and negotiations with regulatory agencies (strong preference: FDA CVM).
- Exceptional communication, negotiation, and influencing skills; able to lead as primary regulatory expert on cross-functional global teams.
Preferred:
- Direct regulatory experience with both farm animal and companion animal products.
- Broad global registration experience; leading first-wave EU and other key market submissions concurrently.
- Experience with novel regulatory pathways for innovative products.
- Risk assessment and risk management fundamentals.
- Continuous improvement knowledge (e.g., Six Sigma, Lean).
Benefits & pay (highlights in posting):
- Up to 6% 401K matching; multiple relocation packages; two weeklong shutdowns (mid-summer and year-end, in addition to PTO); 8-week parental leave; annual bonus offering; flexible work arrangements.
- Base salary range: $118,000–$197,000 (dependent on qualifications/education/experience); eligibility for company bonus.
Application instructions:
- Estimated application closing date is (insert date); applications accepted on an ongoing basis.