Regulatory Counsel

Overview

This role involves providing legal support to ensure compliance with laws and regulations related to the wholesale distribution and export of prescription drugs, medical devices, nutritional products, and food supplements. The Regulatory Counsel will advise on government oversight and enforcement matters and represent the organization during inspections and investigations.

Responsibilities

• Support senior legal leadership on regulatory and legal matters concerning pharmaceutical distribution and export.
• Represent the organization in interactions with government oversight and enforcement agencies.
• Advise on federal and state laws governing domestic and international pharmaceutical distribution, including the Food, Drug & Cosmetic Act, Drug Supply Chain Security Act, BIS and OFAC regulations, patient privacy laws, relevant Executive Orders, and industry best practices.
• Assist in developing, implementing, and updating policies and standard operating procedures related to FDA regulations, supply chain integrity, fraud and abuse statutes, anti-corruption laws, and pharmaceutical industry standards.
• Provide guidance to departments during audits by corporate donors of pharmaceuticals.
• Deliver timely and actionable regulatory and statutory advice to management and department heads.
• Collaborate across departments to develop strategies addressing legal, regulatory, and organizational challenges.
• Proactively identify and mitigate liability risks.
• Support review and quality control of legal work performed by retained counsel in the United States, Germany, and Mexico.
• Perform other duties as assigned by senior legal leadership.

Required Qualifications

• Juris Doctor (J.D.) or Master of Laws (L.L.M.) from an accredited law school.
• Admission to the California Bar in good standing, eligibility to practice as California Registered in-house counsel under California Rules of Court 9.46, or authorization to practice from home jurisdiction.
• Minimum of 5 years of relevant legal experience in a law firm, government, or in-house role.
• Experience interfacing with government oversight and enforcement agencies such as DEA, HHS OIG, FBI, BIS, OFAC, state Boards of Pharmacy, or California Attorney General.
• Demonstrated knowledge of laws and best practices governing pharmaceutical distribution, including FDA regulations, supply chain integrity (DSCSA/FMD), fraud and abuse statutes (Anti-Kickback Statute), privacy laws (HIPAA/GDPR), anti-corruption laws (FCPA), and Good Distribution or Manufacturing Practices.
• Strong written, verbal, and interpersonal communication skills with the ability to influence diverse stakeholders.
• Ability to navigate conflict and work independently with minimal oversight.
• Strong analytical, critical thinking, and problem-solving skills.
• Ability to manage multiple priorities and meet deadlines.
• Successful completion of background check and toxicology screening.

Preferred Qualifications

• Over 5 years of legal experience specifically in the pharmaceutical industry.
• Experience advising on U.S. and/or EU export controls.

Compensation & Benefits

• Generous medical, dental, and vision insurance plans.
• Flexible spending accounts.
• 401(k) retirement plan.
• Accrued paid time off.
• Life insurance and disability coverage.
• Additional life and wellness benefits.

Location

This position requires admission to the California Bar or authorization to practice law from the candidate's home jurisdiction.