Director of Regulatory and Compliance Legal Affairs

Join Our Mission At United Therapeutics, we are pioneering the way as the first publicly-traded biotech firm operating as a public benefit corporation. Our goal is to provide a brighter future for patients by developing innovative pharmaceutical therapies and advancing technologies to expand the availability of transplantable organs. Founded in 1996 out of a family's quest for a cure for pulmonary arterial hypertension (PAH), we proudly offer six FDA-approved therapies addressing PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma, a rare pediatric cancer. Our exciting pipeline is focused on developing additional treatments for PAH and pulmonary fibrosis (PF). With a commitment to addressing the critical shortage of transplantable organs, we are actively researching ways to manufacture organs that could eliminate the transplant waiting list altogether. About the Role The Director of Regulatory and Compliance Legal Affairs will play a vital role in navigating the complex legal landscape of the pharmaceutical and biotech industries. Your expertise will directly support teams across Marketing, Sales, Medical Affairs, Patient Relations, Regulatory Affairs, and Corporate Compliance. Provide expert legal guidance on compliance with healthcare-related laws such as the Food, Drug, and Cosmetic Act, False Claims Act, and Anti-Kickback Statute. Participate as a Legal representative on the promotional review committee, ensuring compliance in promotional and sales training materials. Support the Patient Relations function, advising on reimbursement support and patient navigation programs. Review materials related to HCP consulting activities to ensure compliance standards are met. Represent the legal team on the medical communications review team, assessing Field Medical materials and health economic communications. Assist in developing, reviewing, and updating compliance policies and training materials. Contribute to compliance audits, investigations, and corrective action plans. Provide insights and guidance to the Company's Compliance Committee. Assist in annual Risk Assessment and Mitigation processes to identify and manage risks effectively. Stay informed about changes in the regulatory environment and keep business leaders updated. Manage external counsel on compliance and regulatory issues. Provide supplemental legal support for general corporate issues as needed. Perform other related duties as assigned. Minimum Requirements Juris Doctorate (JD) from an accredited institution. At least 10 years of experience as an attorney. A minimum of 8 years of experience in healthcare and FDA law. 4+ years as in-house legal counsel at a pharmaceutical or biotech company. Strong knowledge of relevant legal issues affecting the lifecycle of pharmaceutical products. Excellent communication and collaboration skills. Proficient in written communication and legal drafting. Skilled in using Mac/PC and MS Office applications. Able to thrive in a fast-paced, dynamic work setting. Preferred candidates will be located in the Eastern Standard Time zone. Willingness to travel to RTP, NC for at least one week each month. Preferred Qualifications Familiarity with Veeva PromoMats. Our team operates with flexibility, allowing for remote work within the United States, with a preference for candidates in RTP, NC. The salary for this position ranges from $230,000 to $285,000, reflecting our commitment to fair compensation based on skills, experience, and geographic location. This role also offers eligibility for short-term and long-term incentive programs. We take pride in our comprehensive benefits package, which includes healthcare options, retirement savings plans, employee wellness resources, and generous paid time off policies. At United Therapeutics, we align our mission with your career aspirations, creating an environment where innovative thinking and dedication to transforming healthcare inspire our daily work. We welcome you to be part of our journey. United Therapeutics Corporation is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace.

Created: 2026-03-04