Senior Principal Scientist – US Regulatory Innovation
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Job Description
Senior Principal Scientist shaping US regulatory strategy for Dechra’s veterinary drugs and biologics. Guiding FDA/USDA submissions, product approvals, and regulatory innovation.
Responsibilities:
- Develop, lead, and deliver innovative, risk-based regulatory strategies for drugs and biotherapeutics
- Identify regulatory risks and opportunities throughout the development lifecycle and develop strategic options
- Provide scientific and regulatory guidance to cross-functional project teams
- Represent the US region on drug and biotherapeutic development teams
- Prepare, review, or oversee regulatory documents, including pre-submission conference requests, protocol concurrences, and Effectiveness and Target Animal Safety technical sections
- Work directly with FDA CVM and USDA CVB on development pathways, protocol concurrence, labeling text, and product approval
- Monitor changing US and global drug and biotherapeutic legislation and share strategic insights with senior stakeholders
- Represent Dechra on external committees, working groups, and trade associations
- Provide senior-level scientific and regulatory leadership to Clinical, CMC, Safety, and DRD/Biotherapeutics Development teams
- Serve as Global RA representative when assigned
- Mentor junior members of the US Innovation Regulatory Affairs team
Requirements:
- University degree (BS, MS, PhD, DVM/VMD) in veterinary medicine, animal sciences, or a related life science discipline
- DVM/VMD preferred; candidates with BS, MS, or PhD may be considered with relevant animal health experience
- Extensive experience in animal health pharmaceutical regulatory affairs, including product development and some safety and efficacy experience
- Hands-on experience with regulatory submissions and approvals from new product development through commercialization
- Experience leading US regulatory submissions for small- and large-molecule biopharmaceutical products
- Success obtaining approvals or advancing products through FDA CVM/USDA CVB submissions
- Strong understanding of US clinical and safety requirements for drug and biopharmaceutical products
- Experience interacting directly with regulatory authorities
- Proven success achieving objectives comparable to those of this position
- Ability to travel domestically and internationally approximately 10–20%
Benefits:
- Competitive salary
- Fully remote work arrangement
- Ability to travel domestically and internationally approximately 10–20%
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