Associate Director, Regulatory Affairs Position Available In Essex, Massachusetts

Job Listing ID:

4293141

Job Title:

Associate Director, Regulatory Affairs Application Deadline:

Open Until Filled

Job Location:

Salem

Date Posted:

06/17/2025

Hours Worked Per Week:

Not Provided Shift:

Not Provided Duration of Job:

Either Full or Part Time, more than 6 months You may contact this employer directly.
(Obtain the contact information to print or add to your jobs.)

Job Summary:

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) . 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. 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. 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 experienc…

Job Classification:

Managers, All Other Access our statewide or regional occupation report for more information about wages,
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Salary:

Not Provided Job Requirements

Experience Required:

 See Job Summary

Education Required:

None

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