Job Information
University of Colorado Regulatory Affairs Program Director in Aurora, Colorado
Regulatory Affairs Program Director - 32624 University Staff
Description
University of Colorado Anschutz Medical Campus
Department: Gates Institute
Job Title: Regulatory Affairs Program Director
Position #00819327 – Requisition #32624
Job Summary:
Key Responsibilities:
Champion the execution of a regulatory strategic plan throughout the lifecycle of each Gates Institute product by providing advanced regulatory guidance, identifying risks, and working cross-functionally to address, sharing clear and timely communication across project teams, and continuously evaluating the feasibility of regulatory strategic plans.
Leading cross-functional collaboration to ensure the preparation and submission of regulatory documentation are of the highest quality.
Manage communications with FDA in collaboration with the University of Colorado Anschutz Medical Campus IND/IDE office, ensuring transparent and proactive agency interactions.
Prepare high-quality IND applications and follow-up submissions (INTERACT, pIND, IND, briefing documents, annual reports) according to set timelines.
Collaborate with other regulatory experts (e.g., CMC, nonclinical, clinical) to ensure seamless integration of all required components.
Work collaboratively to develop regulatory strategy and ensure alignment is reached amongst key stakeholders, including business leaders, clinicians, project managers, and manufacturing experts.
Provide strategic advice to manufacturing, clinical, and nonclinical teams on complex technical topics (as related to candidate's experience).
Work Location:
Hybrid
Why Join Us:
delivering to patients
Diversity and Equity:
Qualifications:
Minimum Qualifications:
A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, business administration, business, or a directly related field from an accredited institution. Substitution : A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
At least 6-8 years of experience in regulatory affairs, with demonstrated experience preparing IND filings.
At least one year of demonstrated experience working in and advising on the unique regulatory landscape of cell and gene therapy (CGT).
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
An advanced Scientific Degree (Ph.D., PharmD., M.D., M.Sc., MSHC) and/or a business qualification (DMS, MBA).
Experience preparing regulatory filings for cell and gene therapy products for a pharmaceutical and/or biotechnology company.
Experience leading and participating in communications with the FDA.
Experience working with and an understanding of the unique pre-clinical, CMC and/or clinical aspects of cell therapy.
Experience managing multiple products simultaneously and at different stages of the product lifecycle.
Strong experience with eCTD format.
3+ years of experience working in cell and/or gene therapy field.
Regulatory Affairs Certification (RAC)
Knowledge, Skills, and Abilities:
Strong communication abilities and a collaborative spirit, capable of influencing and aligning teams across different functions.
Effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams.
Knowledge of the CGT regulatory environment and how this impacts regulatory strategy development and implementation.
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Proven ability to be flexible as solutions, structures, and the organization adapts and changes to meet emerging needs.
Results-driven with an enthusiastic attitude.
How to Apply:
Screening of Applications Begins:
March 31, 2024
Anticipated Pay Range:
ADA Statement:
Background Check Statement:
Vaccination Statement:
vaccine preventable diseases
Job Category
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Join the Gates Institute as a Regulatory Affairs Program Director. This is a full-time University Staff position that serves as a key contributor to the development and execution of product development within the Gates Institute. This role will be responsible for developing regulatory strategy from early discovery through Phase I clinical trials. This position will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
– this role is eligible for a hybrid schedule of 1 day per week on campus and as needed for in-person meetings.
The opportunity offered by the Gates Institute is one of a kind. They blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus – the University of Colorado – Anschutz Medical Campus. The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. They are only limited by their resources and need you to make their journey a success! In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is . The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5011308&targetURL=https://www.cu.edu/employee-services/benefits-wellness)
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Resume 3. Three to five professional references including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: Donna.3.Parker@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5011308&targetURL=Donna.3.Parker@cuanschutz.edu)
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by . Those who do not apply by this date may or may not be considered.
The starting hiring range for the Regulatory Affairs Program Director has been established at $84,992 - $108,110. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position is not eligible for overtime compensation. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=5011308&targetURL=http://www.cu.edu/node/153125)
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu (https://apptrkr.com/get_redirect.php?id=5011308&targetURL=hr.adacoordinator@ucdenver.edu) .
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other https://apptrkr.com/get_redirect.php?id=5011308&targetURL=CU Anschutz strongly encourages vaccination against the COVID-19 virus and other . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get_redirect.php?id=5011308&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .
Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 22128 - ADM CHAN Gates Inst Operating : Full-time : Feb 9, 2024 : Ongoing Posting Contact Name: Donna Parker Posting Contact Email: Donna.3.Parker@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5011308&targetURL=Donna.3.Parker@cuanschutz.edu) Position Number: 00819327jeid-ceb5941ba888784fa235d677677b52c1
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.