Regulatory Strategist Manager

University of Colorado•Aurora, CO

1d•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

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

Responsibilities

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.
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
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