Hawaii Staffing
Associate Director, Regulatory Affairs
Hawaii Staffing, Honolulu, Hawaii, United States, 96814
Regulatory Strategist Opportunity
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. 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. 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. United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
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. 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. 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. United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.