United Therapeutics
Associate Director, Regulatory Affairs
United Therapeutics, Sacramento, California, United States, 95828
Overview
Who we are: United Therapeutics is a publicly traded biotech/pharma company and a public benefit corporation dedicated to developing novel therapies and technologies to expand transplantable organ availability. We pursue treatments for rare diseases and seek to advance organ regeneration through Miromatrix, a United Therapeutics company focused on transplantable organs and bioengineered solutions. We are committed to changing medicine and transplant science within a collaborative culture. Who you are
We are looking for a regulatory strategist who will advise on regulatory pathways, manage documentation and timelines, and support the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Minimum Requirements
12+ years of biologic or pharma regulatory experience with a Bachelor’s Degree in life sciences, quality, regulatory affairs or related field; or 10+ years with a Master’s Degree; or 7+ years with a PhD in life sciences, quality, regulatory affairs or related field. 8+ years of project or people management experience. Experience writing an IND and submitting 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 across functions. Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively in a remote/hybrid environment. Ability to mentor, coach, guide, and train employees at varying levels. Preferred Qualifications
Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312. Job Location
This role is onsite in Eden Prairie, MN (Miromatrix) with an option for a remote candidate with monthly travel if they have 1271 or CBER experience. Salary ranges from $165,000 to $225,000 per year and eligibility for the Company’s short-term and long-term incentive programs. The posted salary range is the range United Therapeutics believes is possible at the time of posting and may be adjusted. Compensation may be higher or lower based on experience, location, and other factors required by law. Wages or compensation are not guaranteed until earned, vested, and determinable under applicable policies and plans. Eligible employees may participate in the Company’s benefits package, including medical/dental/vision/prescription coverage, wellness resources, savings plans (401k and ESPP), paid time off and parental leave, disability benefits, and more. For benefits information, 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, transforming work into mission and achievement into success.
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Who we are: United Therapeutics is a publicly traded biotech/pharma company and a public benefit corporation dedicated to developing novel therapies and technologies to expand transplantable organ availability. We pursue treatments for rare diseases and seek to advance organ regeneration through Miromatrix, a United Therapeutics company focused on transplantable organs and bioengineered solutions. We are committed to changing medicine and transplant science within a collaborative culture. Who you are
We are looking for a regulatory strategist who will advise on regulatory pathways, manage documentation and timelines, and support the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Minimum Requirements
12+ years of biologic or pharma regulatory experience with a Bachelor’s Degree in life sciences, quality, regulatory affairs or related field; or 10+ years with a Master’s Degree; or 7+ years with a PhD in life sciences, quality, regulatory affairs or related field. 8+ years of project or people management experience. Experience writing an IND and submitting 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 across functions. Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively in a remote/hybrid environment. Ability to mentor, coach, guide, and train employees at varying levels. Preferred Qualifications
Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312. Job Location
This role is onsite in Eden Prairie, MN (Miromatrix) with an option for a remote candidate with monthly travel if they have 1271 or CBER experience. Salary ranges from $165,000 to $225,000 per year and eligibility for the Company’s short-term and long-term incentive programs. The posted salary range is the range United Therapeutics believes is possible at the time of posting and may be adjusted. Compensation may be higher or lower based on experience, location, and other factors required by law. Wages or compensation are not guaranteed until earned, vested, and determinable under applicable policies and plans. Eligible employees may participate in the Company’s benefits package, including medical/dental/vision/prescription coverage, wellness resources, savings plans (401k and ESPP), paid time off and parental leave, disability benefits, and more. For benefits information, 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, transforming work into mission and achievement into success.
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