Department: OVCR Investigational New Drug/ Device Office

Job Title: Regulatory Strategist Program Manager

Position #: 846482 - Requisition #: 40584

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.

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
• Direct experience with IND and/or IDE submissions to FDA, specifically CBER and CDRH, including but not limited to: exemption determinations, requests for determination, as well as preparation for FDA INTERACT, pre-IND, and/or q-submission meetings
• Experience with ARPH-H projects
• Previous experience with the creation of CMC sections and other content supporting IND/IDE submissions

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.

Knowledge, Skills and Abilities:

• 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.
• 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

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
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:

Screening of Applications Begins:

Immediately and continues until the position has been filled. For best consideration, apply by August 10, 2026.

Anticipated Pay Range:

The starting salary range for this position has been established as $74,627 - $100,000.

The above salary 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.

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