Job Description

We are seeking a strategic, relationship-oriented Regulatory Specialist to serve as a key interagency liaison between ARPA-H (Advanced Research Projects Agency for Health) and the U.S. Food and Drug Administration (FDA). In this pivotal role, you’ll help drive cross-agency alignment, regulatory clarity, and collaborative opportunities that enable breakthrough biomedical innovations to advance toward commercialization and patient impact.

The ideal candidate brings first-hand FDA experience, excels at managing multi-stakeholder communications, and thrives in fast-paced, mission-driven environments. Prior exposure to ARPA-style innovation programs (e.g., DARPA, ARPA-E, BARDA) is highly desirable.

Key Responsibilities:

• Build and maintain productive relationships with FDA personnel and other federal agency contacts.
• Provide direct regulatory coordination and strategic guidance to ARPA-H Program Managers in collaboration with FDA liaisons.
• Support ARPA-H’s Project Accelerator Transition Innovation Office (PATIO) by identifying and facilitating access to relevant regulatory consultants and tools.
• Track and support intergovernmental engagements aligned with ARPA-H priorities, including agencies under HHS and beyond.
• Maintain and update engagement records within the internal tracking system and produce regular interagency collaboration dashboards.
• Draft briefing materials, regulatory engagement summaries, and written reports for ARPA-H leadership.
• Develop tailored presentations for external agency meetings and manage scheduling, prep, and logistics for interagency engagements.

Qualifications

Required Qualifications:

• Bachelor's degree from an accredited institution.
• Minimum 3 years of professional experience at the FDA, with a strong understanding of regulatory pathways (e.g., IND, IDE, 510(k), PMA, etc.).
• Proficiency in contract research management tools and regulatory tracking systems.
• Demonstrated ability to work across agencies and departments with professionalism and discretion.
• Exceptional writing, presentation development, and communication skills.
• Strong organizational abilities with experience managing multiple concurrent priorities.
• Proficiency in Microsoft PowerPoint, Excel, and related collaboration tools.

Preferred Qualifications:

• 2–3 years supporting ARPA-style organizations or high-risk, high-reward R&D programs (e.g., DARPA, ARPA-E, BARDA, IARPA).
• Familiarity with the federal health innovation ecosystem, including NIH, CMS, and HHS.
• Experience preparing for and coordinating regulatory agency meetings (e.g., pre-IND, pre-submission).

Additional Information

• Job Type: Full-Time
• Location: One Franklin Square, 1301 K Street NW, Suite 1200 West, Washington, D.C.
• Remote Work: Hybrid (up to 60% remote)
• Clearance Requirement: Eligible for Public Trust
• Compensation: Commensurate with experience