US Regulatory Innovation Lead for Biologics & Small Molecules

Dechra Pharmaceuticals PLC; Boston, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Dechra Pharmaceuticals PLC seeks a Regulatory Affairs Senior Principal Scientist to lead regulatory strategies for traditional small‑molecule drugs and large‑molecule biotherapeutics in the US. You will guide submissions, liaise with FDA CVM/USDA CVB, and mentor the US Innovation Regulatory Affairs team to ensure timely development and registration.

The role requires strong expertise in US regulatory requirements, strategic risk assessment, and cross‑functional collaboration, with travel ~10–20%.

Qualifications

• Extensive experience in animal health pharmaceutical regulatory affairs.
• Experience with regulatory submissions from development through commercialization.
• Strong understanding of US clinical and safety requirements for biopharmaceuticals.
• Proven success in obtaining regulatory approvals in the US.

Responsibilities

• Develop and lead regulatory strategies for drugs and biotherapeutics in the US.
• Advise on regulatory readiness and project direction across development lifecycles.
• Coordinate with FDA CVM/USDA CVB on development pathways and labeling.
• Provide senior scientific/regulatory leadership to cross‑functional teams.
• Represent Dechra on external committees and contribute to policy.

Skills

Regulatory strategy development

US FDA regulatory submissions

Biologics regulatory affairs

Cross-functional collaboration

Leadership & mentoring

Education

DVM/VMD preferred

BS/MS/PhD in life sciences

Job description

Dechra Pharmaceuticals PLC seeks a Regulatory Affairs Senior Principal Scientist to lead regulatory strategies for traditional small‑molecule drugs and large‑molecule biotherapeutics in the US. You will guide submissions, liaise with FDA CVM/USDA CVB, and mentor the US Innovation Regulatory Affairs team to ensure timely development and registration.

The role requires strong expertise in US regulatory requirements, strategic risk assessment, and cross‑functional collaboration, with travel ~10–20%.