Regulatory Strategy Lead – Biologics & Small Molecules

Dechra Pharmaceuticals Limited; United States; À distance; USD 140 000 - 210 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

FDA CVM/USDA CVB experience

Leadership/mentoring

Clinical safety and efficacy

Cross-functional collaboration

Regulatory submissions

US drug regulations

Formation

BS/MS/PhD in veterinary medicine or life sciences

DVM/VMD preferred

Description du poste

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.