Senior Scientist, Global Regulatory Lead
Elanco
August 23, 2026
Remote friendly (Indianapolis, IN)
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 regulatory subject matter expert on development teams; provide risk/benefit evaluations to guide project 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 for Quality, Safety, and Efficacy sections of regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities.
- Comply with company local and global policies (quality frameworks, Code of Conduct, anti-discrimination/harassment, HSE).
Minimum Qualifications:
- 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 (preference: FDA CVM).
- Ability to serve as primary regulatory expert on cross-functional global teams with strong communication, negotiation, and influencing skills.
Preferred Qualifications:
- Direct regulatory experience with both farm animal and companion animal products.
- Experience with global registration processes; leading first-wave EU and other simultaneous submissions.
- Experience navigating novel regulatory pathways.
- Risk assessment/management fundamentals.
- Continuous Improvement knowledge (e.g., Six Sigma, Lean).
Additional Information:
- Travel: 10–25%.
- US-based role; Hybrid in Indianapolis, IN (Global Headquarters) or remote.
Benefits Highlights:
- Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; Employee Resource Groups; annual bonus; flexible work arrangements; up to 6% 401(k) matching.
Application Instructions:
- Estimated application closing date: (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 regulatory subject matter expert on development teams; provide risk/benefit evaluations to guide project 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 for Quality, Safety, and Efficacy sections of regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities.
- Comply with company local and global policies (quality frameworks, Code of Conduct, anti-discrimination/harassment, HSE).
Minimum Qualifications:
- 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 (preference: FDA CVM).
- Ability to serve as primary regulatory expert on cross-functional global teams with strong communication, negotiation, and influencing skills.
Preferred Qualifications:
- Direct regulatory experience with both farm animal and companion animal products.
- Experience with global registration processes; leading first-wave EU and other simultaneous submissions.
- Experience navigating novel regulatory pathways.
- Risk assessment/management fundamentals.
- Continuous Improvement knowledge (e.g., Six Sigma, Lean).
Additional Information:
- Travel: 10–25%.
- US-based role; Hybrid in Indianapolis, IN (Global Headquarters) or remote.
Benefits Highlights:
- Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; Employee Resource Groups; annual bonus; flexible work arrangements; up to 6% 401(k) matching.
Application Instructions:
- Estimated application closing date: (insert date). Applications accepted on an ongoing basis.