What are the responsibilities and job description for the Associate Director, Regulatory Affairs position at United Therapeutics?
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 bio-artificial 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
We are looking for a regular strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the preparation and execution of regulatory submissions for our whole tissue engineering program. Are you looking to fundamentally change medicine and transplant science while working as part of a brilliant, kind and collaborative culture? Who wouldn’t – apply here!
Minimum Requirements
- 12 years of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10 years of biologic or pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7 years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or a related area of study
- 8 years of project or people management experience
- Must have written an IND and submitted it in ECTD format through the ESG portal
- Proven track record in successfully navigating regulatory submissions
- Proven ability to lead and influence data-driven strategy planning and implementation
- Strong leadership and communication skills with success in influencing all levels cross-functionally
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment
- Ability to mentor, coach, guide, and train lower to senior level employees
Preferred Qualifications
- Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312
Job Location
This role is located onsite in our Eden Prairie, MN (Miromatrix) location.
The salary for this position ranges from $165,000 to $225 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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
https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Salary : $165,000 - $225,000
