Regulatory Counsel

Overview

This role involves supporting an organization's compliance with laws, regulations, and best practices related to the wholesale distribution and export of prescription drugs, medical devices, nutritional products, and food supplements. The Regulatory Counsel will also advise and represent the organization in matters involving government oversight and enforcement actions.

Responsibilities

• Support and report to senior legal leadership on legal and regulatory matters focused on wholesale distribution and export of pharmaceuticals and related products.
• Represent the organization during inspections and investigations by government oversight and enforcement agencies.
• Provide advice 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.
• Advise on the development, implementation, and updating of policies and standard operating procedures related to FDA regulations, supply chain integrity, fraud and abuse statutes, anti-corruption statutes, and pharmaceutical industry standards.
• Support departments during audits by corporate donors of pharmaceuticals.
• Deliver timely and actionable regulatory and statutory advice to management and department heads.
• Collaborate with various departments to develop strategies addressing legal, regulatory, and organizational challenges.
• Proactively identify and mitigate liability risks.
• Assist in reviewing and quality-controlling 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 domestic and/or international pharmaceutical distribution, including FDA regulations under the Food, Drug & Cosmetic Act, supply chain integrity (DSCSA/FMD), fraud and abuse (Anti-Kickback Statute), privacy (HIPAA/GDPR), anti-corruption (FCPA), and Good Distribution or Manufacturing Practices.
• Strong written, verbal, and interpersonal communication skills with the ability to influence diverse stakeholders and operate with minimal oversight.
• Excellent analytical, critical thinking, and problem-solving abilities.
• Ability to adapt to changing priorities and manage multiple assignments with 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 allows for practice under California Bar admission or equivalent authorization from the candidate's home jurisdiction.