Senior Scientist, Global Regulatory Lead
New
United StatesFull-TimeSenior
SalaryUSD 118000 - 197000 / year
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Job Details
- Experience
- At least 10 years
- Required Skills
- Project Management
Requirements
- 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 familiarity 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.
- Exceptional communication, negotiation, and influencing skills.
- Ability to travel 10-25%.
Responsibilities
- Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVM/FDA submissions.
- Serve as the dedicated regulatory subject matter expert on development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
- Act as the primary point of contact for and lead direct engagements with regulatory agencies (e.g., CVM, European Medicines Agency (EMA)), including pre-submission meetings and negotiations.
- Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
- 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 to the development team and leadership.
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