Regulatory Strategist Program Manager

Job Summary:

Reporting to the Assistant 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 and Project Management - 50%

• 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 early phase drug development and proactively identify potential challenges

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

• Development and implementation of regulatory strategy processes consistent with departmental strategies for large scales, multi-stakeholder projects such as ARPA-H initiatives.

External Consultant and Subcontractor Management - 25%

• 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 - 25%

• 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,

• Assists in CMC dossier preparation and/or technical manufacturing sections for investigator held INDs and/or IDEs,

• 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:

• Bachelor's degree from an accredited institution.

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

4-6 years of professional experience in analytical development, early phase drug development, and regulatory strategy.

Substitution: An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• 7+ years of professional experience in analytical development, early phase drug development, and regulatory strategy.

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