Regulatory Strategist Manager

Job Summary:

Reporting to the Program Director of the IND/IDE Office in the Office of the Vice Chancellor for Research (OVCR), the IND/IDE Office Regulatory Strategist is a high impact and high visibility role, responsible for developing strategy, engaging external consultants and regulatory support for studies at CU Anschutz that are supported by the IND/IDE Office. This role will work closely with other leaders in the OVCR, Cancer Center, Gates Institute, and CHCO to support CU held INDs and CU investigator-held INDs. The mission of this group is to partner with CU Anschutz investigators and stakeholders to develop innovative therapies and facilitate the regulatory and operational conduct of clinical trials. This role requires expertise in FDA regulations (21 CFR Parts 312, 812) and serves as a primary strategist for complex regulatory submissions, such as those funded by ARPA-H that may require interactions with multiple other institutions and external consultants.

Key Responsibilities:

Regulatory Strategy:

• Support investigators in the development and implementation of a regulatory strategy to help support their locally held IND/IDE studies

• Lead development discussions with campus and external stakeholders to ensure that the regulatory strategy for a given IND/IDE and clinical trial meet the objectives of the institution and funding agency

• Aid in the education and mentorship for faculty to help them understand regulatory needs and limitations

• Present to funding agencies and campus leadership on the proposed and selected regulatory strategy

• Maintain a thorough understanding of regulatory requirements and proactively identify potential challenges

• Interpret and apply regulatory requirements in a practical and strategic manner.

Engage and Manage External Consultants and Subcontractors:

• Review grant and funding proposals to determine if external consulting or subcontracts are needed in order to achieve the desired goals of the grant/contract.

• Identify and engage with the appropriate 3rd party consulting, if deemed necessary

• Manage the vendor relationship with consultants and ensure that all work is appropriately delegated and adequate oversight is provided

• Ensure timely identification of issues with contractors, including need to end arrangements if consultants are not meeting contractual obligations

Regulatory Specialist Responsibilities:

• Serves as the primary point of contact for other internal/external contributors to the FDA submissions. This includes direct communications and meetings about the project with regulatory compliance, scientific review committees, the manufacturing sites, the hospital-based research administration, and other entities on campus as needed,

• Serves as the primary point of contact with external entities, such as outside suppliers of materials, and FDA,

• Meets regularly with the PI and study team to review content and progress of application packages to various branches of FDA,

• Ensures all required documentation and sections/modules for submissions to FDA are complete and formatted per FDA requirements; identifies missing or incomplete documentation, tracks and manages requests for outstanding documentation, and performs submissions throughout the project's lifecycle to FDA per agency's requirement,

• Maintains version control for documentation throughout the IND/IDE's life cycle,

• Identifies and elevates barriers delaying any FDA submissions, assists with identifying solutions,

• Ensures currency and completeness of Trial Master Files for projects under IND/IDE Office oversight,

• Assists in developing and providing Standard Operating Procedures, educational resources and training for IND/IDE Office team members and investigators and their research teams

• Other relevant tasks as delegated by the supervisor or leadership

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 2 days per week on campus and as needed for in-person meetings.

Why Join Us:

The IND/IDE Program at CU Anschutz was established in 2023 under the directive of the Vice Chancellor for Research, Dr. Thomas Flaig.

The team consists of the IND/IDE Office (Vice Chancellor for Research) and the Cancer Center (School of Medicine). Research projects will be triaged to either entity based on project type and therapeutic area.

The program provides expertise and assistance to researchers involved in the development and clinical assessments of novel health solutions for investigator-initiated studies. We do this by partnering with research teams to centrally manage the responsibilities that are unique to the role of being a regulatory sponsor for FDA-regulated research.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability, Life, Vision

• Retirement 401(a) Plan: Employer contributes 10% of your gross pay

• Paid Time Off: Accruals over the year

• Vacation Days: 22/year (maximum accrual 352 hours)

• Sick Days: 15/year (unlimited maximum accrual)

• Holiday Days: 15/year

• Tuition Benefit: Employees have access to this benefit on all CU campuses

• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

Manager:

• Bachelor's degree from an accredited institution

• 4-6 years of professional experience in Regulatory Support and Strategy

• Experience with the creation of CMC sections and other content supporting IND/IDE submissions

• A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• 5+ years of experience in regulatory affairs within the healthcare industry

Knowledge, Skills and Abilities:

• Strong knowledge of FDA regulations and the drug development process

• Ability to work independently and manage multiple projects simultaneously

• Ability to build and maintain strong relationships with cross-functional teams

• 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.

Conditions of Employment:

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

How to Apply:

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 (only use if a cover letter is necessary)

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Tiffany Cull, Tiffany.Cull@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until April 13, 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $77,736 - $95,393

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

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

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

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@cuanschutz.edu.

Background Check Statement:

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.

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.