Oklahoma Staffing
Associate Director, Regulatory Affairs
Oklahoma Staffing, Oklahoma City, Oklahoma, United States, 73116
Regulatory Strategist Opportunity
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 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. Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis. 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 technology has the potential to be applied across the spectrum of donor needs. We are focused on the research and development of transplantable kidneys, livers, and a bioengineered external liver assist device for acute liver failure, with plans to also bioengineer other critical organs like lungs, pancreases and hearts. 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 This role is located onsite in our Eden Prairie, MN location with the option for a remote candidate with monthly travel if they have 1271 or CBER experience. 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. 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.
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 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. Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis. 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 technology has the potential to be applied across the spectrum of donor needs. We are focused on the research and development of transplantable kidneys, livers, and a bioengineered external liver assist device for acute liver failure, with plans to also bioengineer other critical organs like lungs, pancreases and hearts. 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 This role is located onsite in our Eden Prairie, MN location with the option for a remote candidate with monthly travel if they have 1271 or CBER experience. 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. 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.