Counsel, Regulatory – Pharmacy

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide guidance to the business on matters related to regulatory compliance across all jurisdictions where the company operates, including all 50 states.

• Offer support and counsel to Enablement, Operations, Research and Development, Fulfillment, Licensing, and Quality concerning compounding, pharmacy operations, API manufacturing, and associated issues.

• Advise cross-functional teams on pharmacy-related regulatory matters, legal risks, and compliance with federal and state laws governing pharmacies and other facilities.

• Identify concerns related to privacy, care delivery, litigation, and product issues, collaborating with the legal team to further business objectives.

• Assist the Litigation team in responding to regulatory inquiries and complaints from state Boards of Pharmacy and the FDA.

• Remain updated on state and federal pharmacy laws, regulations, and guidance.

• Aid in the development and enforcement of facility policies and standard operating procedures (SOPs) that align with the company’s values and legal responsibilities.

⛳️ Requirements

• Juris Doctor degree from an ABA-accredited law school.

• Active license to practice law in at least one jurisdiction in the U.S.

• Minimum of 5 years of experience in healthcare regulatory affairs.

• At least 2 years of experience providing guidance in the pharmacy sector.

• Familiarity with state and federal laws, rules, and regulations relevant to 503A and/or 503B pharmacy facilities and operations.

• A keen interest in developing expertise in state and federal compounding laws is preferred.

• Proven ability to provide innovative, solution-oriented advice.

• Team-oriented, collaborative mindset with a positive attitude and a focus on growth.

• Capability to adapt swiftly and take initiative in a dynamic, fast-paced setting.

• Strong skills in time management and project prioritization.

• Exceptional judgment.

• Ability to identify issues and coordinate efforts across the legal team and various business units.

• Experience engaging with licensing and regulatory authorities such as the FDA or state Boards of Pharmacy is advantageous.

• Legally permitted to work in the U.S. without restrictions for any employer.

• Must not require immigration sponsorship by Hims & Hers in order to work in the U.S.

🏝️ Benefits

• Competitive salary and equity compensation for full-time positions.

• Unlimited paid time off (PTO).

• Company-observed holidays.

• Quarterly mental health days.

• Medical, dental, and vision benefits.

• Parental leave.

• Employee Stock Purchase Program (ESPP).

• Employee discounts on Hims & Hers products.

• 401(k) plan with employer matching contributions.

• Offsite team retreats.

• Flexible and remote work options.

• Reasonable accommodations for qualified individuals with disabilities and disabled veterans.