VP, U.S. Regulatory Affairs

Hims & Hers

7d

About The Position

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.

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.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 11-50 employees