Regulatory Affairs Director jobs in Colorado

Job Summary:

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.

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:

Why Join Us:

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 delivering to patients.

Diversity and Equity:

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.

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:

For full consideration, please submit the following document(s):

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

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by March 10, 2024. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

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.

Total Compensation Calculator:

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Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. 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.