VP, U.S. Regulatory Affairs

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals. About the Role: Hims & Hers is seeking a VP of U.S. Regulatory Affairs to lead the company’s regulatory strategy, filings, and regulatory intelligence in the U.S. market. This role is responsible for developing and executing a cohesive regulatory approach that supports product innovation, market expansion, and long-term compliance across digital health, telemedicine, pharmacy, consumer health, AI, and emerging care categories. The VP of U.S. Regulatory Affairs provides strategic regulatory guidance, manages all regulator-facing submissions, anticipates regulatory risks and opportunities, and equips cross-functional partners with the insights and requirements needed to operate in a complex and evolving regulatory landscape. You’ll collaborate closely with other functions, including Legal, Quality & Safety, Product, Clinical, Pharmacy, Marketing, and Global Affairs, to ensure the company is prepared, informed, and aligned as we navigate FDA, DEA, FTC, and other applicable regulatory requirements. You may also be asked to work on state or international regulatory issues as needed. Experience in U.S. healthcare regulation, FDA/OTC/consumer health pathways, or digital health regulatory strategy is required. You Will: • 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. You Have: • 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. Our Benefits (there are more but here are some highlights): • 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 We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement. 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