Summary:

The Regulatory Counsel will support the organization's adherence to laws, regulations, and best practices applicable to the wholesale distribution and export of prescription drugs, medical devices, nutritional products, and food supplements.  The position will also advise and represent the organization in connection with government oversight and enforcement actions.

The successful candidate will have meaningful legal experience relevant to the pharmaceutical manufacturing/distribution, healthcare, or similar regulated industries.

Key Duties & Responsibilities:

As directed by the Senior Counsel and/or the Vice President of Legal & Regulatory Affairs, the Regulatory Counsel will perform functions including, but not limited, to, the following:

• Support and report to the Senior Counsel and Vice President of Legal & Regulatory Affairs on legal and regulatory matters, with a focus on laws and regulations applicable to wholesale distribution and export of prescription drugs, medical devices, and other products.
• Represent Direct Relief in connection with inspections and investigations by government oversight and enforcement agencies.
• Advise on application and implementation of federal and state laws relating to governing the domestic and international distribution of pharmaceuticals, including the Food Drug & Cosmetic Act, the Drug Supply Chain Security Act, BIS and OFAC regulations, patient privacy laws, relevant Executive Orders, and pharmaceutical industry trends and best practices.
• Advise on the development, implementation, and update of policies and standard operating procedures implementing FDA regulations, supply chain integrity requirements, fraud and abuse statutes, anti-corruption statutes, and pharmaceutical industry best practices.
• Advise relevant departments in connection with audits by corporate donors of pharmaceuticals.
• Provide timely, actionable regulatory and statutory advice to management and department heads upon request.
• Work collaboratively with all departments to develop strategies and resolutions to unique legal, regulatory, and/or organizational challenges.
• Proactively identify and mitigate liability risks in the workplace.
• Support the Legal and Regulatory Affairs department in the review and quality-control of legal work performed by Direct Relief’s retained counsel in the United States, Germany, and Mexico.
• Support the Senior Counsel and the Vice President of Legal and Regulatory Affairs on other duties as assigned.

Required Qualifications:

• Experienced legal practitioner with 5 or more years of relevant experience in a law firm, government, and/or in-house position.
• J.D. or L.L.M. from an accredited law school.
• Admitted member in good standing of the California Bar, eligible to practice as California Registered in-house counsel under California Rules of Court 9.46, or otherwise authorized to practice from home jurisdiction.
• Experience interfacing with government oversight and enforcement agencies (such as the Drug Enforcement Agency (DEA), HHS Office of Inspector General (OIG), Federal Bureau of Investigation (FBI), Bureau of Industry and Security (BIS), Office of Foreign Assets Control (OFAC), state Boards of Pharmacy, or California Attorney General).
• Demonstrable knowledge of the laws and best practices governing the domestic and/or international distribution of pharmaceuticals, such as 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 Practices or Good Manufacturing Practices.
• Strong written, verbal, and interpersonal communication skills; ability to influence diverse stakeholders; comfort navigating conflict and operating with minimal oversight.
• Strong analytical, critical thinking, and problem-solving skills.
• Adaptive to changing priorities and able to juggle multiple assignments with deadlines.
• Clear background check and toxicology screening.

Desired Qualifications:

• 3+ years of legal experience in the pharmaceutical industry.
• Experience advising on US and/or EU export controls.

About Direct Relief

Direct Relief is a top-rated, California-based humanitarian nonprofit organization that provides emergency medical supplies, medications, and resources to people impacted by poverty, natural disasters, and civil conflict. It ranks among the world’s most efficient and innovative charities, operating in 80+ countries and all 50 U.S. states and territories.

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