This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Regulatory Affairs – Clinical in the United States.
This is a high-impact regulatory leadership role within a clinical-stage biotech environment focused on advancing innovative veterinary medicines. You will serve as a key authority on FDA Center for Veterinary Medicine (CVM) clinical regulatory strategy, guiding programs from early development through pivotal submissions. The role requires deep expertise in regulatory pathways, strong scientific judgment, and the ability to operate in complex, first-of-its-kind development programs with limited precedent. You will act as the primary regulatory interface with FDA CVM for clinical matters, shaping submission strategy, clinical trial compliance, and regulatory interactions. Working closely with clinical, R&D, CMC, and cross-functional teams, you will ensure regulatory alignment across all development stages. This position offers the opportunity to directly influence the approval path of groundbreaking longevity therapeutics and help define a new category in veterinary medicine.
Accountabilities:- Lead FDA CVM clinical regulatory strategy across the development lifecycle, including INAD management, pivotal submissions, and regulatory interaction planning.
- Author, review, and oversee regulatory submissions such as study protocols, IND/INAD filings, amendments, safety reports, and formal agency correspondence.
- Serve as the primary liaison with FDA CVM for clinical regulatory matters, including meeting preparation, briefing packages, and post-meeting follow-up.
- Provide real-time regulatory guidance to clinical and development teams on ongoing studies, including safety reporting, BIMO readiness, and compliance requirements.
- Monitor and interpret FDA CVM guidance, policy updates, and precedent to inform evolving regulatory strategy across programs.
- Identify, assess, and mitigate regulatory risks across R&D, clinical operations, and CMC functions to ensure program continuity and compliance.
- Manage and mentor junior regulatory staff, supporting capability building, prioritization, and professional development within the team.
Requirements
- Bachelor’s degree in biology, veterinary medicine, regulatory affairs, or a related scientific field (advanced degree preferred).
- 10+ years of regulatory affairs experience, with strong focus on FDA CVM interactions and animal health drug development.
- Proven hands-on experience leading INADs, regulatory submissions, and FDA CVM meetings in a clinical development context.
- Deep expertise in FDA CVM regulatory pathways, guidance documents, and submission requirements across drug development stages.
- Strong scientific and analytical thinking skills, with the ability to interpret complex data and translate it into regulatory strategy.
- Excellent written and verbal communication skills, with experience producing high-quality regulatory documentation and submissions.
- Demonstrated ability to operate independently as a senior subject matter expert while collaborating across multidisciplinary teams.
- Leadership experience mentoring or managing junior regulatory professionals in fast-paced, dynamic environments.
Benefits
- Competitive salary range: $155,000 – $205,000
- Full medical, dental, and vision insurance coverage for employees and dependents
- Equity options grant for new hires
- $1,200 annual learning and development budget
- $250 monthly wellness stipend (gym, wellness, lifestyle expenses)
- Home office equipment stipend of $1,000
- Unlimited vacation and paid holidays
- Additional long weekends (4-day weekends for all 3-day weekends)
- Paid paw-ternity leave for new pet adoption
- Remote-first flexibility and startup environment
- Inclusive culture with strong values around collaboration, learning, and innovation.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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