Regulatory Affairs Manager

California, US residents .

The job details are as follows:

Who we are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who you are

You are a Regulatory Affairs professional looking to join a supportive, collaborative team. You have experience managing regulatory submissions, a solid working knowledge of regulatory requirements, and are looking for the opportunity to lead projects supporting late phase drug development and marketing application submissions.

The Regulatory Affairs Manager will function as the regulatory lead for assigned products/projects, coordinating cross-functional activities with internal product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical) to adhere to timelines. They will prepare and maintain new and existing regulatory applications, including investigational and marketing applications (IND/CTAs, NDAs, MAAs, etc.) and other submissions in compliance with health authority regulations. They will serve as the company's representative for assigned products/projects, engaging with various regulatory agencies, CROs, and partner organizations, as necessary. They will collaborate with relevant functional disciplines to ensure sound regulatory product development strategy and execution.

Minimum Requirements

Preferred Qualifications

Job Location

This job will be located at our Durham, NC office. Currently this is a hybrid role requiring at least 4 days per week in the office, with the option to work from home 1 day per week. In office requirements could increase based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.