Sr. Regulatory Counsel (Pharmacy)

Hims & Hers

3d

About The Position

Hims & Hers is seeking an experienced Sr. Regulatory Counsel to join our growing, collaborative and dynamic Legal team. You will have the opportunity to provide teams from across the company with actionable legal advice on various pharmacy laws, rules, and regulations impacting the products and services offered through Hims & Hers. You will get to work on interesting and novel issues that arise from the intersection of healthcare, technology, and e-commerce.

Requirements

• Juris Doctor from an ABA-accredited law school and current active license to practice law in at least one US jurisdiction
• 9+ years of healthcare regulatory experience, with at least 5 years advising in the pharmacy space.
• Familiarity and experience interpreting and advising on state and federal laws, rules, and regulations applicable to a variety of pharmacy facilities (503A and/or 503B) and operations. An interest in developing subject matter expertise in state and federal compounding laws is desired.
• Strong record of providing creative, solution-focused advice.
• Team-oriented, collaborative mindset and positive attitude.
• Ability to adapt quickly and take initiative in a dynamic, fast-paced environment.
• Strong time management and project prioritization skills.
• Impeccable judgment.
• Ability to issue spot and coordinate cross-functional efforts across the legal team and business units.

Nice To Haves

• Experience interacting with licensing/regulatory authorities such as the FDA or state Boards of Pharmacy is a plus

Responsibilities

• Advise the business on a variety of regulatory compliance matters across all jurisdictions where the company does business, including all 50 states.
• Support and advise multiple business units, including but not limited to the Research and Development, Enablement, Operations and Fulfillment, Quality, and Compounding Production teams on issues related to pharmacy operations, compounding, supply chain, facility network development, facility licensing, and more.
• Advise cross-functional teams across the business on a broad variety of pharmacy regulatory issues and considerations related to legal risks. Understand the federal, state, and local laws, rules, and regulations impacting the practice and operations of pharmacies and other facilities, including compounding, resident and non-resident mail order pharmacy operations, and more.
• Identify issues that may touch upon privacy, care delivery, litigation, and product issues, working collaboratively with other members of the legal team to move business objectives forward.
• Assist, in collaboration with the Litigation team, with responses to regulatory inquiries and complaints, including but not limited to correspondence from state Boards of Pharmacy and the FDA.
• Stay up-to-date on relevant state and federal laws, regulations, and guidance around pharmacy operations.
• Support the development and enforcement of facility policies and SOPs, ensuring alignment with company values and legal obligations.

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: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees