United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.
The job details are as follows:
What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.
In 2021, we became the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
How you’ll contribute
Initiate and provide strategic regulatory guidance and direction leading to successful registration for new devices and combination products and new indications for existing devices and combination products. Provide strategic regulatory input, support, and oversight to junior regulatory personnel (including direct reports), project teams, and other departments. Additionally, interface directly with UT partner organizations, regulatory agencies, management of regulatory submissions, and regulatory department-related activities.
- Initiate, identify, and provide medical device and combination product strategic regulatory guidance and support to multifunctional medical device operations and drug development teams in support of global product development and life-cycle activities and regulatory agency interactions
- Identify, propose, plan and direct regulatory strategies for, and management/preparation of, regulatory submissions to regulatory agencies, including scientific and technical review for regulatory compliance and completeness; this includes managing and interacting with internal and external persons to achieve the successful acceptance of regulatory applications
- Serve as the company’s Regulatory Device representative with UT commercial and development partners and regulatory agencies; prepare internal and external participants for regulatory interactions and lead these interactions
- Actively mentor, coach and develop direct reports; plan and manage direct reports' workload, assign or delegate tasks, as appropriate
- Assess impact of changing regulations on submission and product development strategies and updates internal/external stakeholders in a timely manner
- Performs due diligence activities, as requested
- Other duties as assigned
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) in a scientific discipline
- 15+ years of experience in regulatory affairs
- 6+ years of experience in medical devices
- 5+ years of people management experience
- Competency with MS Office Products and document management systems
- Subject matter expert on device and/or combination product regulations and guidelines in the US and/or EU
- Highly effective communicator (written and verbal)
- Master’s degree (MA/MS/MBA) in a scientific discipline or
- Doctor of Philosophy (PhD) in a scientific discipline
- 13+ years of experience in regulatory affairs with a Master's Degree or
- 10+ years of experience in regulatory affairs with a PhD
- Regulatory Affairs Certifications (RAC)-RAPS
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities