Counsel, Regulatory (Pharmacy)

Hims & Hers•,

1d•$175,000 - $210,000

About The Position

Hims & Hers is seeking an experienced Regulatory Counsel to join its Legal team. The role provides actionable legal advice to teams across the company on pharmacy laws, rules, and regulations affecting the products and services offered through Hims & Hers. It involves novel issues at the intersection of healthcare, technology, and e-commerce, and supports business teams across all jurisdictions where the company operates, including all 50 states. The Counsel will advise business units on matters involving compounding, pharmacy operations, API manufacturing, and related topics; identify and coordinate issues involving privacy, care delivery, litigation, and products; assist with responses to regulatory inquiries and complaints; monitor applicable legal developments; and support facility policies and standard operating procedures. This is a full-time role, as indicated by the description of benefits for full-time roles.

Requirements

Juris Doctor from an ABA-accredited law school.
Current, active license to practice law in at least one U.S. jurisdiction.
At least 5 years of healthcare regulatory experience, including at least 2 years advising in the pharmacy space.
Familiarity with and experience interpreting and advising on state and federal laws, rules, and regulations applicable to pharmacy facilities, including 503A and/or 503B facilities, and their operations.
Strong record of providing creative, solution-focused advice.
Team-oriented, collaborative approach, growth 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 spot issues and coordinate cross-functional efforts across the Legal team and business units.

Nice To Haves

Interest in developing subject matter expertise in state and federal compounding laws.
Experience interacting with licensing or regulatory authorities such as the FDA or state Boards of Pharmacy.

Responsibilities

Advise the business on regulatory compliance matters across all jurisdictions where the company does business, including all 50 states.
Support and advise business units, including Enablement, Operations, Research and Development, Fulfillment, Licensing, and Quality, on compounding, pharmacy operations, API manufacturing, and related issues.
Advise cross-functional teams on pharmacy regulatory issues, legal considerations, and risks.
Understand federal and state laws, rules, and regulations affecting the practice and operation of pharmacies and other facilities.
Identify issues involving privacy, care delivery, litigation, and products, and collaborate with other members of the Legal team to advance business objectives.
Work with the Litigation team on responses to regulatory inquiries and complaints, including correspondence from state Boards of Pharmacy and the FDA.
Stay current on relevant state and federal laws, regulations, and guidance concerning pharmacy operations.
Support the development and enforcement of facility policies and standard operating procedures, ensuring alignment with company values and legal obligations.