Associate Director, Regulatory Affairs

United Therapeutics; Salem (OR); Hybrid; USD 165,000 - 225,000; Full time

Job summary

A biotechnology company is seeking a regulatory strategist to advise on regulatory pathways and manage submissions for whole organ tissue engineering. The ideal candidate will have over 12 years of regulatory experience in biologics or pharmaceuticals, with strong leadership and communication skills. This role offers a competitive salary range of $165,000 to $225,000 and benefits designed to foster employee wellness and engagement.

Benefits

Medical, dental, and vision coverage

401k and ESPP

Paid time off and parental leave

Qualifications

• 12+ years of biologic or pharma regulatory experience.
• Proven ability to lead/data-driven strategy.
• Experience mentoring and coaching.

Responsibilities

• Advise on regulatory pathways and manage documentation.
• Support preparation and execution of regulatory submissions.
• Collaborate with colleagues and stakeholders.

Skills

Leadership

Communication

Project Management

Regulatory Submissions

Interpersonal Skills

Education

Bachelor's Degree in life sciences, quality, regulatory affairs, or related

Master's Degree in life sciences, quality, regulatory affairs, or related

PhD in life sciences, quality, regulatory affairs, or related

Job description

Overview

California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9).

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.

Miromatrix, A United Therapeutics company was created to bring our vision of a world without an organ transplant waitlist to life. With an average of 17 people dying each day waiting for a life-saving organ, the need for a solution is more critical than ever.

Founded in 2009 from the University of Minnesota's breakthrough advances in perfusion decellularization and recellularization technology, we are the world leader in the research and development of fully biologic organs. Our approach is expected to be an efficient way to answer the unmet need of thousands of patients across the country who will otherwise go without the transplant they need to survive and thrive.

Miromatrix has 140 issued patents worldwide. Our technology has the potential to be applied across the spectrum of donor needs. We are focused on the research and development of transplantable kidneys (mirokidney), livers (miroliver), and a bioengineered external liver assist device for acute liver failure (miroliver ELAP), with plans to also bioengineer other critical organs like lungs, pancreases and hearts.

Position

Who you are

We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the preparation and execution of regulatory submissions for our whole organ 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 with the option for a remote candidate with monthly travel if they have 1271 or CBER experience.

Compensation and Benefits

The salary for this position ranges from $165,000 to $225,000 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.

Benefits and EEO

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.

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.