Counsel, Regulatory (Pharmacy)

Overview

The organization is seeking an experienced Regulatory Counsel to join its Legal team. This role provides actionable legal advice to business teams across the organization on pharmacy laws, rules, and regulations impacting products and services delivered through an e-commerce and technology-driven health and wellness platform. The work involves legal issues at the intersection of healthcare, technology, and online commerce.

Responsibilities

• Advise the business on regulatory compliance matters across all jurisdictions where the organization does business, including all 50 states.
• Support and advise multiple business units, including Enablement, Operations, Research and Development, Fulfillment, Licensing, and Quality, on issues related to compounding, pharmacy operations, API manufacturing, and related areas.
• Advise cross-functional teams on pharmacy regulatory issues and legal risk considerations.
• Understand and apply federal and state laws, rules, and regulations impacting the practice and operation of pharmacies and other facilities.
• Identify issues that may relate to privacy, care delivery, litigation, and product matters, working collaboratively with other members of the legal team to move business objectives forward.
• Collaborate 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 affecting pharmacy operations.
• Support development and enforcement of facility policies and SOPs, ensuring alignment with legal obligations.

Requirements

• Juris Doctor from an ABA-accredited law school.
• Current active license to practice law in at least one US jurisdiction.
• 5+ years of healthcare regulatory experience, including at least 2 years advising in the pharmacy space.
• Familiarity with interpreting and advising on state and federal laws, rules, and regulations applicable to pharmacy facilities and operations, including 503A and/or 503B.
• Interest in developing subject matter expertise in state and federal compounding laws is desired.
• Proven ability to provide creative, solution-focused advice.
• Team-oriented, collaborative approach, with 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 identify legal issues and coordinate cross-functional efforts across the legal team and business units.

Preferred Qualifications

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

Compensation & Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental, and vision, plus parental leave.
• Employee Stock Purchase Program (ESPP).
• Employee discounts.
• 401k benefits with employer matching contribution.
• Offsite team retreats.

Additional Information

• The organization considers qualified applicants for employment, including applicants with arrest or conviction records, in accordance with applicable fair chance laws.
• Massachusetts law prohibits requiring or administering a lie detector test as a condition of employment or continued employment.
• Reasonable accommodations are available for qualified individuals with disabilities and disabled veterans as part of the application process.