VP, U.S. Regulatory Affairs
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Job Description
VP of U.S. Regulatory Affairs leading regulatory strategy for Hims & Hers. Overseeing regulatory compliance and filings for digital health and telemedicine initiatives.
Responsibilities:
- Lead the development of the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products, among others.
- Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
- Provide regulatory intelligence—monitoring federal and other regulatory activity (e.g., FDA, DEA, CMS, and other regulatory agencies) and synthesizing developments into clear, actionable insights for internal teams.
- Advise Product, Quality & Safety, Clinical, Pharmacy, Marketing, and other teams on regulatory expectations related to product development, market entry, claims, labeling, and operational requirements.
- Draft and manage regulatory collateral, including submission packages, responses to regulator inquiries, comments or correspondence to regulators, internal regulatory guidance documents, and documentation required for licensing expansion.
- Partner with Regulatory Legal on interpretation of statutes and regulations, enforcement risk, and legal strategy; translate legal interpretations into practical guidance for operational teams.
- Support Global Affairs with technical regulatory input to strengthen advocacy, regulatory engagement, and public-facing policy positions.
- Serve as a regulatory representative in external interactions with regulators, consultants, standards bodies, or working groups, providing technical and operational context as needed.
- As needed, build and lead a lean, high-performing Regulatory Affairs team, managing prioritization, coaching, and professional development.
- Contribute to the development of a forward-looking regulatory roadmap that demonstrates that Hims & Hers is a safe, compliant, and innovative leader in digital healthcare and consumer wellness.
Requirements:
- Bachelor’s degree required; advanced degree preferred (JD, PharmD, MPP, MPH, MS Regulatory Affairs, or related).
- 15+ years of experience in regulatory affairs, health policy, healthcare compliance, life sciences, digital health, or related sectors.
- Required: Experience working with FDA-regulated products or compliance frameworks, or experience within a U.S. healthcare regulatory agency or comparable regulatory environment.
- Demonstrated experience preparing or managing regulatory submissions, licensing activities, or regulatory documentation.
- Strong understanding of FDA regulatory pathways, OTC and consumer health regulation, telehealth/telemedicine oversight, pharmacy regulations, and digital health policy environments.
- Proven ability to interpret and translate regulatory requirements into clear, actionable guidance for cross-functional teams.
- Exceptional writing, analytical, and communication skills, with the ability to clearly explain complex regulatory issues to technical and non-technical audiences.
- Experience working cross-functionally with other teams such as legal, product, clinical, pharmacy, quality, and policy teams in a fast-moving environment.
Benefits:
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats
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