Counsel, Regulatory (Pharmacy)

Bazeta; United States; Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

401k with employer matching

Employee discounts

Job summary

Hims & Hers, a leading health and wellness platform, seeks an experienced Regulatory Counsel to advise on pharmacy laws and regulations. You will support multiple business units across operations, licensing, and quality, addressing issues at the federal and state levels and coordinating with the FDA and state Boards of Pharmacy as needed.

You will stay current on regulatory developments and help craft policies that align with company values, ensuring compliant product and service delivery in a

Qualifications

• Juris Doctor from an ABA-accredited law school
• Active license to practice law in at least one US jurisdiction
• 5+ years of healthcare regulatory experience, with focus on pharmacy regulations

Responsibilities

• Advise the business on a broad range of regulatory compliance matters across all jurisdictions in which the company operates, including all 50 states.
• Support and advise multiple business units on pharmacy operations, compounding, API manufacturing, licensing and quality issues.
• Provide cross-functional regulatory guidance to mitigate legal risk for pharmacy facilities and related services.
• Identify issues touching privacy, care delivery, litigation, and product matters, collaborating with the legal team to advance business objectives.
• Assist with responses to regulatory inquiries and complaints, including correspondence with state Boards of Pharmacy and FDA.
• Stay current on state and federal pharmacy laws, regulations, and guidance; help develop and enforce facility policies and SOPs.

Education

Juris Doctor (ABA-accredited law school)

Job description

4. Counsel, Regulatory (Pharmacy)# Counsel, Regulatory (Pharmacy)## DescriptionHims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.Hims & Hers is a public company, traded on the NYSE under the ticker symbol \"HIMS.\" To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works. For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.About the Role:Hims & Hers is seeking an experienced 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.You Will:-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 Enablement, Operations, Research and Development, Fulfillment, Licensing and Quality on issues related to compounding, pharmacy operations, API manufacturing 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 and state laws, rules, and regulations impacting the practice and operation of pharmacies and other facilities.-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.You Have:-Juris Doctor from an ABA-accredited law school and current active license to practice law in at least one US jurisdiction-5+ years of healthcare regulatory experience, with at least 2 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 and possess a 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 issue spot and coordinate cross-functional efforts across the legal team and business units.-Experience interacting with licensing/regulatory authorities such as the FDA or state Boards of Pharmacy is a plusOur Benefits (there are more but here are some highlights):-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)-Employee discounts on hims & hers-401k benefits with employer matching contribution-Offsite team retreatsWe are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply - even if you're not sure if your background or experience is a perfect match.Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.Source: Jobicy (https://jobicy.com/jobs/159354-counsel-regulatory-pharmacy)