U.S. Regulatory Affairs VP

Job Summary

A company is looking for a VP of U.S. Regulatory Affairs to lead its regulatory strategy and compliance efforts.

Key Responsibilities

• Develop and execute the company's U.S. regulatory strategy for various health-related products
• Oversee regulatory filings, submissions, and registrations with relevant agencies
• Provide regulatory intelligence and guidance to internal teams on compliance and operational requirements

Required Qualifications

• Bachelor's degree required; advanced degree preferred (e.g., JD, PharmD, MPH)
• 15+ years of experience in regulatory affairs or related fields
• Experience with FDA-regulated products or within a U.S. healthcare regulatory agency
• Strong understanding of FDA regulatory pathways and telehealth regulations
• Proven ability to translate regulatory requirements into actionable guidance for teams