FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and leading regulatory strategies for drugs and biotherapeutics, with a strong focus on compliance with US clinical and safety requirements. Proven ability to mentor teams and provide scientific guidance while successfully navigating regulatory submissions and approvals.
Highest-signal resume keywords
Regulatory Affairs LeadershipFDA CVM/USDA CVB SubmissionsAnimal Health Pharmaceutical ExperienceRegulatory Strategy DevelopmentCross-Functional Team Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionsProduct DevelopmentSafety and Efficacy ExperienceRegulatory Document PreparationRisk-Based Regulatory StrategiesClinical Requirements UnderstandingBiopharmaceutical Product ApprovalMentoringStrategic Insights SharingLegislation Monitoring
Soft Skills
LeadershipCommunicationCollaborationMentoringStakeholder Engagement
Certifications & Qualifications
DVM/VMD PreferredUniversity Degree in Veterinary Medicine or Related Life Science
Industry Keywords
Animal HealthBiotherapeuticsDrug DevelopmentRegulatory RisksUS Regulatory AuthoritiesGlobal Regulatory ComplianceTrade AssociationsClinical DevelopmentCMCSafety
About the role
Key responsibilities & impact- Develop, lead, and deliver innovative, risk-based regulatory strategies for drugs and biotherapeutics
- Identify regulatory risks and opportunities throughout the development lifecycle and develop strategic options
- Provide scientific and regulatory guidance to cross-functional project teams
- Represent the US region on drug and biotherapeutic development teams
- Prepare, review, or oversee regulatory documents, including pre-submission conference requests, protocol concurrences, and Effectiveness and Target Animal Safety technical sections
- Work directly with FDA CVM and USDA CVB on development pathways, protocol concurrence, labeling text, and product approval
- Monitor changing US and global drug and biotherapeutic legislation and share strategic insights with senior stakeholders
- Represent Dechra on external committees, working groups, and trade associations
- Provide senior-level scientific and regulatory leadership to Clinical, CMC, Safety, and DRD/Biotherapeutics Development teams
- Serve as Global RA representative when assigned
- Mentor junior members of the US Innovation Regulatory Affairs team
Requirements
What you’ll need- University degree (BS, MS, PhD, DVM/VMD) in veterinary medicine, animal sciences, or a related life science discipline
- DVM/VMD preferred; candidates with BS, MS, or PhD may be considered with relevant animal health experience
- Extensive experience in animal health pharmaceutical regulatory affairs, including product development and some safety and efficacy experience
- Hands-on experience with regulatory submissions and approvals from new product development through commercialization
- Experience leading US regulatory submissions for small- and large-molecule biopharmaceutical products
- Success obtaining approvals or advancing 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 achieving objectives comparable to those of this position
- Ability to travel domestically and internationally approximately 10–20%
Benefits
Comp & perks- Competitive salary
- Fully remote work arrangement
- Ability to travel domestically and internationally approximately 10–20%