US Regulatory Innovation Lead for Biotherapeutics

Dechra; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Dechra, an international veterinary pharmaceutical company, seeks a Regulatory Affairs Senior Principal Scientist to lead regulatory strategies for traditional small molecules and biologics in the US, shaping development paths and ensuring timely approvals.

The role mentors US team members, collaborates with FDA CVM/USDA CVB and cross-functional teams, and represents Dechra on external committees, with domestic/international travel ~10–20%.

Qualifications

• Extensive experience in animal health pharmaceutical regulatory affairs.
• Strong track record with US regulatory submissions and approvals.
• Experience collaborating with cross-functional teams and external regulators.
• Ability to mentor junior staff and lead RA projects.
• Demonstrated success navigating FDA CVM/USDA CVB processes.

Responsibilities

• Develop and implement risk-based regulatory strategies for drugs and biologics.
• Identify regulatory risks early and propose strategic options.
• Provide guidance to cross-functional teams on regulatory readiness.
• Represent US on project teams and align with global strategies.
• Prepare and review regulatory documents and submissions.

Skills

Regulatory affairs leadership

US FDA CVM/USDA CVB experience

Cross-functional collaboration

Regulatory submissions

Strategic regulatory planning

Education

BS/MS/PhD/DVM/VMD in life sciences

Job description

Dechra, an international veterinary pharmaceutical company, seeks a Regulatory Affairs Senior Principal Scientist to lead regulatory strategies for traditional small molecules and biologics in the US, shaping development paths and ensuring timely approvals.

The role mentors US team members, collaborates with FDA CVM/USDA CVB and cross-functional teams, and represents Dechra on external committees, with domestic/international travel ~10–20%.