Hims & Hers is hiring a VP, U.S. Regulatory Affairs to lead our regulatory strategy, filings, and intelligence. In this role, you will develop a cohesive regulatory approach that supports product innovation, market expansion, and long-term compliance across our digital health, telemedicine, pharmacy, consumer health, and emerging care categories.
What You'll Do
- Lead the development of the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.
- Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
- Provide regulatory intelligence—monitoring federal and other regulatory activity and synthesizing developments into clear, actionable insights.
- 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, and internal guidance documents.
- Partner with Regulatory Legal on interpretation of statutes and regulations, and translate legal interpretations into practical guidance for operational teams.
- Support Global Affairs with technical regulatory input to strengthen advocacy and regulatory engagement.
- Serve as a regulatory representative in external interactions with regulators, consultants, standards bodies, or working groups.
- As needed, build and lead a lean, high-performing Regulatory Affairs team.
- Contribute to the development of a forward-looking regulatory roadmap.
What We're Looking For
- Bachelor’s degree.
- 15+ years of experience in regulatory affairs, health policy, healthcare compliance, life sciences, digital health, or related sectors.
- Experience working with FDA-regulated products or compliance frameworks, or experience within a U.S. healthcare regulatory agency.
- 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 teams such as legal, product, clinical, pharmacy, quality, and policy teams in a fast-moving environment.
Nice to Have
- Advanced degree preferred (JD, PharmD, MPP, MPH, MS Regulatory Affairs, or related).
Team & Environment
You will collaborate closely with Legal, Quality & Safety, Product, Clinical, Pharmacy, Marketing, and Global Affairs.
Benefits & Compensation
- 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
Hims is committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with fair chance laws.
