Regulatory Strategist Manager
University of Colorado, Aurora, CO, United States
Regulatory Strategist Manager
University of Colorado Anschutz Medical Campus
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.
Work Location Hybrid. Eligible for a schedule of 2 days per week on campus and as needed for in‑person meetings.
Key Responsibilities
Regulatory Strategy
Support investigators in the development and implementation of a regulatory strategy to help support locally held IND/IDE studies.
Lead development discussions with campus and external stakeholders to ensure the strategy meets institutional and funding agency objectives.
Aid in the education and mentorship of 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
Review grant and funding proposals to determine if external consulting or subcontracts are needed.
Identify and engage appropriate third‑party consultants if necessary.
Manage vendor relationships and ensure work is delegated and overseen.
Ensure timely identification of issues with contractors and make arrangements to end engagement if necessary.
Regulatory Specialist Responsibilities
Serve as primary point of contact for internal and external contributors to FDA submissions.
Meet regularly with PI and study team to review content and progress of application packages.
Ensure all required documentation and sections for FDA submissions are complete and formatted per FDA requirements, track requests.
Maintain version control for documentation throughout the IND/IDE lifecycle.
Identify and elevate barriers to FDA submissions, assist with solutions.
Ensure currency and completeness of Trial Master Files for projects under IND/IDE Office oversight.
Assist in developing and providing SOPs, educational resources, and training for office team members and investigators.
Perform other relevant tasks as delegated.
Benefits
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22 per year (maximum accrual 352 hours)
Sick Days: 15 per year (unlimited maximum accrual)
Holiday Days: 15 per year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service
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 experience may be substituted for a bachelor's degree on a year‑for‑year basis.
Preferred Qualifications
5+ years of experience in regulatory affairs within the healthcare industry.
Knowledge, Skills & 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.
Effective oral and written communication skills.
Ability to establish and maintain relationships with employees at all levels of the institution.
Outstanding customer service skills.
Conditions of Employment
Applicants must be legally authorized to work in the United States without requiring sponsorship. This position does not provide visa sponsorship or employment authorization.
Pay Range $77,736 – $95,393
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University of Colorado Anschutz Medical Campus
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.
Work Location Hybrid. Eligible for a schedule of 2 days per week on campus and as needed for in‑person meetings.
Key Responsibilities
Regulatory Strategy
Support investigators in the development and implementation of a regulatory strategy to help support locally held IND/IDE studies.
Lead development discussions with campus and external stakeholders to ensure the strategy meets institutional and funding agency objectives.
Aid in the education and mentorship of 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
Review grant and funding proposals to determine if external consulting or subcontracts are needed.
Identify and engage appropriate third‑party consultants if necessary.
Manage vendor relationships and ensure work is delegated and overseen.
Ensure timely identification of issues with contractors and make arrangements to end engagement if necessary.
Regulatory Specialist Responsibilities
Serve as primary point of contact for internal and external contributors to FDA submissions.
Meet regularly with PI and study team to review content and progress of application packages.
Ensure all required documentation and sections for FDA submissions are complete and formatted per FDA requirements, track requests.
Maintain version control for documentation throughout the IND/IDE lifecycle.
Identify and elevate barriers to FDA submissions, assist with solutions.
Ensure currency and completeness of Trial Master Files for projects under IND/IDE Office oversight.
Assist in developing and providing SOPs, educational resources, and training for office team members and investigators.
Perform other relevant tasks as delegated.
Benefits
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22 per year (maximum accrual 352 hours)
Sick Days: 15 per year (unlimited maximum accrual)
Holiday Days: 15 per year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service
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 experience may be substituted for a bachelor's degree on a year‑for‑year basis.
Preferred Qualifications
5+ years of experience in regulatory affairs within the healthcare industry.
Knowledge, Skills & 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.
Effective oral and written communication skills.
Ability to establish and maintain relationships with employees at all levels of the institution.
Outstanding customer service skills.
Conditions of Employment
Applicants must be legally authorized to work in the United States without requiring sponsorship. This position does not provide visa sponsorship or employment authorization.
Pay Range $77,736 – $95,393
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