Making life better for animals, makes life better.
Senior Scientist, Global Regulatory Lead
Location
United States
Posted
2 days ago
Salary
$118K - $197K / year
Seniority
Senior
Job Description
Senior Scientist, Global Regulatory Lead
Elanco
• 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
Job Requirements
- 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
- 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
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