Senior Principal Scientist, US Regulatory Innovation

Dechra Pharmaceuticals Limited; United States; Remote; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Dechra Pharmaceuticals Limited in the United States seeks a Regulatory Affairs Senior Principal Scientist to lead forward-looking regulatory strategies for traditional small molecules and large biologics, ensuring development programs meet US expectations.

You will mentor team members, interact with FDA CVM/USDA CVB, prepare submissions, and represent global RA on cross-functional teams across US and international programs.

Qualifikationen

• Advanced degree in veterinary medicine or life sciences.
• Extensive experience in animal health regulatory affairs, incl. safety and efficacy.
• Proven proficiency with regulatory submissions and approvals, US focus.

Aufgaben

• Develop, lead, and deliver regulatory strategies for drugs and biotherapeutics in the US.
• Identify regulatory risks and opportunities early and craft strategic options.
• Provide scientific and regulatory guidance to cross-functional teams for readiness and development.
• Represent the US region on cross-functional development teams and ensure alignment with US expectations.
• Prepare, review, or oversee regulatory documents, including submission-related sections.
• Engage with FDA CVM/USDA CVB on development pathways and labeling text.
• Stay updated on US and global legislation and communicate insights to senior stakeholders.
• Represent Dechra on external committees and regulatory policy discussions.
• Provide senior-level leadership to Clinical, CMC, Safety and Biotherapeutics teams.

Kenntnisse

Regulatory strategy

FDA CVM/USDA CVB experience

Leadership/mentoring

Clinical safety and efficacy

Cross-functional collaboration

Regulatory submissions

US drug regulations

Ausbildung

BS/MS/PhD in veterinary medicine or life sciences

DVM/VMD preferred

Jobbeschreibung

Welcome to DechraDechra is an international veterinary pharmaceutical business focused on specialty products. We develop, manufacture, sell and market high-quality products exclusively for veterinarians around the world.

Job PurposeThe Regulatory Affairs Senior Principal Scientist leads and delivers thoughtful, forward-looking regulatory strategies for the clinical safety and efficacy of traditional small-molecule drugs and large-molecule biotherapeutics, including monoclonal antibodies and other complex biologics, in the US.

This role identifies regulatory opportunities and risks early, develops strategic options and helps ensure regulatory pathways support successful and timely product development across all US programs.

The role may also represent Global RA on project teams and work with regional RA teams to support a global registration strategy. In addition, the Senior Principal Scientist mentors junior members of the US Innovation Regulatory Affairs team, helping them build technical regulatory skills in clinical safety and efficacy.

Key Responsibilities

• Develop, lead, and deliver innovative, risk‑based regulatory strategies for drugs and biotherapeutics (e.g., monoclonal antibodies, protein therapeutics).
• Identify regulatory risks and opportunities early and develop strategic options to address or make the most of them throughout the development lifecycle.
• Provide scientific and regulatory guidance to cross‑functional project teams, supporting strategic decisions, regulatory readiness and continued development of regulatory expertise.
• Represent the US region on cross‑functional drug and biotherapeutic development teams and help ensure alignment with US regulatory expectations.
• Prepare, review, or oversee regulatory documents, including pre-submission conference requests, protocol concurrences, and Effectiveness and Target Animal Safety technical sections, helping the US Innovation RA team maintain consistent, high standards.
• Work directly with FDA CVM/USDA CVB to discuss and agree on development pathways, protocol concurrence, labeling text and product approval.
• Keep up to date with changing US and global drug and biotherapeutic legislation and share clear, strategic insights with senior stakeholders.
• Represent Dechra on relevant external committees, working groups and trade associations for drugs and biotherapeutics, contributing to agency guidance and regulatory policy.
• Provide senior-level scientific and regulatory leadership to Clinical, CMC, Safety and DRD/Biotherapeutics Development teams.
• Serve as Global RA representative when assigned, helping ensure alignment with EU, US, and international SMEs.

Skills & Experience

• University degree (BS, MS, PhD, DVM/VMD) in veterinary medicine, animal sciences, or a related life science discipline.
• DVM/VMD is preferred. Candidates with other backgrounds (BS, MS, PhD) may also be considered if they have relevant animal health experience.
• Extensive experience in animal health pharmaceutical regulatory affairs, including supporting product development, with some experience focused on safety and efficacy.
• Demonstrated proficiency and hands‑on experience with regulatory submissions and approvals, from new product development through commercialization.
• Proven experience leading regulatory submissions for small and large‑molecule biopharmaceutical products in the US.
• Demonstrated success obtaining approvals or advancing drug and biopharmaceutical 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 in achieving objectives comparable to those of this position.

Ability to travel (domestic/international) approximately 10-20%.