Senior Principal Scientist – US Regulatory Innovation

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, lead, and implement innovative, risk-based regulatory strategies for pharmaceuticals and biotherapeutics.

• Identify regulatory risks and opportunities throughout the development lifecycle, formulating strategic options.

• Provide scientific and regulatory direction to cross-functional project teams.

• Represent the US region on drug and biotherapeutic development teams.

• Prepare, review, or supervise regulatory documents, such as pre-submission conference requests, protocol agreements, and technical sections on Effectiveness and Target Animal Safety.

• Collaborate directly with FDA CVM and USDA CVB on development pathways, protocol agreements, labeling text, and product approval processes.

• Stay informed on evolving US and global drug and biotherapeutic legislation, sharing strategic insights with senior stakeholders.

• Represent Dechra in external committees, working groups, and trade associations.

• Provide senior-level scientific and regulatory leadership to Clinical, CMC, Safety, and DRD/Biotherapeutics Development teams.

• Act as Global RA representative when assigned.

• Mentor junior members of the US Innovation Regulatory Affairs team.

⛳️ Requirements

• Bachelor's, Master's, PhD, or DVM/VMD degree in veterinary medicine, animal sciences, or a related life science field.

• DVM/VMD is preferred; candidates with a BS, MS, or PhD may be considered if they have relevant animal health experience.

• Extensive experience in animal health pharmaceutical regulatory affairs, including product development along with some safety and efficacy involvement.

• Practical experience with regulatory submissions and approvals, from new product development to commercialization.

• Experience leading US regulatory submissions for both small- and large-molecule biopharmaceutical products.

• Proven success in obtaining approvals or advancing products through FDA CVM/USDA CVB submissions.

• Strong grasp of US clinical and safety requirements for drug and biopharmaceutical products.

• Experience in direct interactions with regulatory authorities.

• Demonstrated success in achieving objectives similar to those outlined for this position.

• Willingness to travel domestically and internationally approximately 10–20% of the time.

🏝️ Benefits

• Competitive salary.

• Fully remote work arrangement.

• Opportunity to travel domestically and internationally approximately 10–20%.