hims & hers · 4 days ago
VP, U.S. Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$300K/yr - $360K/yr
15+ years expHims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. The VP of U.S. Regulatory Affairs will lead the company’s regulatory strategy, filings, and regulatory intelligence in the U.S. market, ensuring compliance and supporting product innovation and market expansion.
Health CareLifestyleMen'sWellnessWomen's
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
Qualification
Required
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
Company
hims & hers
Hims is a wellness brand that helps men and women get access to products for skin care, hair loss, and sexual health.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.23BKey Investors
Franklin TempletonIVPThrive Capital
2025-05-08Post Ipo Debt· $1B
2021-01-21Post Ipo Equity· $75M
2021-01-21IPO
Leadership Team
Andrew Dudum
Founder & CEO
Yemi Okupe
CFO
Recent News
dcm.com
2025-12-31
Company data provided by crunchbase