Senior Principal Scientist – US Regulatory Innovation

Job not on LinkedIn

🕒 October 9

🇺🇸 United States – Remote

💵 $147k - $191k / year

⏰ Full Time

🟠 Senior

🧬 Research Scientist

👻 Ghost score 13%

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Dechra

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💊 Pharmaceuticals

🏥 Healthcare

💰 IPO on 2000-08

Pharmaceuticals • Healthcare

Dechra is an international veterinary pharmaceuticals and related products business. The company develops, supplies and supports high‑quality medicines and allied products exclusively for veterinarians and veterinary professionals worldwide. Dechra emphasizes veterinary-focused services—providing clinical support, professional education through Dechra Academy, and global distribution and sustainability efforts—positioning itself as a partner to veterinary professionals to improve animal health and wellbeing.

📋 Description

• 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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