VP of U.S. Regulatory Affairs

About the Role:

• Lead the company's regulatory strategy, filings, and regulatory intelligence in the U.S. market.
• Develop and execute a cohesive regulatory approach that supports innovation, expansion, and long-term compliance.
• Manage regulator-facing submissions and anticipate regulatory risks.

You Will:

• Oversee regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
• Advise teams on regulatory expectations related to product development, market entry, claims, labeling, and operational requirements.
• Partner with legal on interpretation of statutes and regulations, enforcement risk, and legal strategy.

You Have:

• 15+ years of experience in regulatory affairs, health policy, healthcare compliance, life sciences, digital health, or related sectors.
• Strong understanding of FDA regulatory pathways, OTC and consumer health regulation, telehealth/telemedicine oversight, pharmacy regulations, and digital health policy environments.
• Exceptional writing, analytical, and communication skills.