US Regulatory Innovation Lead – Biologics & Small Molecules

Dechra; Boston (MA); On-site; USD 150,000 - 220,000; Full time

Job summary

Dechra, a leading veterinary pharmaceutical company, seeks a Regulatory Affairs Senior Principal Scientist to lead regulatory strategies for traditional small‑molecule drugs and biologics in the US. You will identify risks and opportunities, mentor junior staff, and collaborate with FDA CVM/USDA CVB to align development pathways and labeling.

You will shape regulatory submissions, provide cross‑functional guidance, and represent US RA on global teams, ensuring timely product development and

Qualifications

• University degree (BS, MS, PhD, DVM/VMD) in veterinary medicine, animal sciences, or a related life science discipline.
• Extensive experience in animal health pharmaceutical regulatory affairs, including supporting product development, with some experience focused on safety and efficacy.
• 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.

Responsibilities

• Develop, lead, and deliver regulatory strategies for drugs and biotherapeutics in the US.
• Identify regulatory risks and opportunities early and develop strategic options.
• Provide scientific and regulatory guidance to cross‑functional teams, supporting regulatory readiness.
• Represent the US region on cross‑functional drug and biotherapeutic development teams.
• Prepare, review, or oversee regulatory documents, including pre‑submission conference requests and protocol concurrences.
• Work with FDA CVM/USDA CVB to discuss development pathways and labeling text.
• Stay up to date with changing US and global regulations and share insights with senior stakeholders.
• Represent Dechra on external committees and regulatory policy discussions.
• Provide senior‑level scientific and regulatory leadership to Clinical, CMC, Safety and Biotherapeutics teams.
• Serve as Global RA representative when assigned.

Skills

Regulatory affairs

US FDA CVM/USDA CVB knowledge

Biotherapeutics regulatory experience

Strategic regulatory planning

Cross-functional leadership

Education

DVM/VMD preferred

BS/MS/PhD in life sciences

Job description

Dechra, a leading veterinary pharmaceutical company, seeks a Regulatory Affairs Senior Principal Scientist to lead regulatory strategies for traditional small‑molecule drugs and biologics in the US. You will identify risks and opportunities, mentor junior staff, and collaborate with FDA CVM/USDA CVB to align development pathways and labeling.

You will shape regulatory submissions, provide cross‑functional guidance, and represent US RA on global teams, ensuring timely product development and