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 16%

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DECA

WebsiteLinkedInAll Job Openings

11 - 50 employees

💼 Consulting

💸 Finance

🤝 B2B

Consulting • Finance • B2B

DECA is a Puerto Rico–based advisory firm that helps companies navigate the island’s incentives, tax, compliance, and capital-access programs. It uses a technology-driven, analytics-backed approach to streamline processes and maximize available monetary incentives. Core services include entity foundational set-up, incentives decree applications, ongoing compliance and tax advisory, and access-to-capital solutions such as monetizable R&D and tourism tax credits, local cash grants for R&D and manufacturing, federal R&D grants, federal green energy credits (ITC/PTC), cash grant and tax credit bridge financing, equipment financing, working capital lines of credit, and building acquisition financing.

📋 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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