# Regulatory Affairs Supervisor Remote from[USA](https://jobicy.com/job-region/usa.md)Salary, yearly, USD 71,517 - 90,970Department [Legal & Compliance](https://jobicy.com/categories/legal.md) Employment type Full Time, Job posted5 Jun 2026Apply before5 Jul 2026Experience level Midweight Views / Applies 3458 / 1344 [About company](https://jobicy.com/company/university-of-colorado.md) [Share](#share) About [University of Colorado](https://jobicy.com/company/university-of-colorado.md) CU is on a mission to highlight the impact our campuses have on Coloradans' everyday lives through an open dialogue to better support the things they care about. * [Higher Education](https://jobicy.com/company-category/higher-education.md) * 1876 Actively Hiring Verified job posting This job post has been [manually reviewed](https://jobicy.com/tools/help-center/employee/how-does-jobicy-verify-the-legitimacy-of-remote-job-listings.md) for authenticity and compliance. 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Upgrade to Plus ### AI Summary The Regulatory Affairs Supervisor oversees a regulatory unit within the Cancer Clinical Trials Office at the University of Colorado Anschutz Medical Campus. This role ensures compliance with FDA, OHRP, NCI, and institutional regulations, supervises regulatory staff, and provides mentorship and training. Responsibilities include managing workload, conducting quality assurance audits, and collaborating with investigators and sponsors. The position also contributes to process improvement and serves as a backup for the Regulatory Manager. A hybrid work schedule is available after six months. ### Role DNA Job Complexity Easy Hard Pace & Pressure Relaxed Fast-paced Autonomy Level Guided Full Ownership Communication Load Independent Highly Collaborative AI Insight The role requires a strong understanding of complex regulatory frameworks and supervisory skills, but the difficulty is moderated by available guidance from the Regulatory Manager and established procedures. ### Salary Analysis Median Market Rate USD81,244US Market USD75k – 125k 0 USD138k AI Insight The offered salary range of $71,517 to $90,970 is competitive for an academic medical center regulatory affairs supervisor role in Colorado, aligning with market rates for similar positions in the US. ### Key Skills Regulatory Compliance Clinical Trials FDA Regulations Leadership Quality Assurance OnCore Process Improvement Team Management Mentorship ### Cover Letter Sample I am writing to express my strong interest in the Regulatory Affairs Supervisor position at the University of Colorado Anschutz Medical Campus. With over five years of experience in clinical trial regulatory management, I have developed expertise in FDA, OHRP, and NCI compliance requirements. My background includes supervising regulatory teams, streamlining submission processes, and conducting audits to ensure adherence to the highest standards. I am particularly drawn to the Cancer Clinical Trials Office’s mission to advance oncology research. In my current role, I have successfully led regulatory units, mentored staff, and implemented process improvements that reduced approval timelines by 20%. I am confident that my leadership skills and regulatory knowledge will contribute to the success of your clinical trials. Thank you for considering my application. I look forward to the opportunity to discuss how my experience aligns with the needs of the CCTO. Please feel free to contact me at your convenience. Copy ### Possible Interview Questions How do you ensure compliance with FDA and OHRP regulations in a clinical trial setting?I stay updated on regulatory changes through continuous education and implement standard operating procedures that align with current guidelines. I also conduct regular audits and training sessions to ensure the team understands and follows protocols.Describe a time you resolved a conflict within your regulatory team.In a previous role, two team members disagreed on the priority of tasks. I facilitated a meeting to understand both perspectives, realigned their responsibilities based on workload and expertise, and implemented a shared calendar system to improve transparency and collaboration.How would you handle a situation where a protocol amendment needs urgent submission but your team is already overloaded?I would assess the current workload, reprioritize tasks, and temporarily redistribute non-urgent duties among the team. If necessary, I would communicate with the Regulatory Manager to seek additional support or adjust deadlines for less critical submissions.What experience do you have with electronic regulatory management systems like OnCore?I have used OnCore for five years to track regulatory documents, manage submissions, and maintain audit trails. I also trained junior staff on its use and developed best practice guides to ensure accurate data entry.How do you keep your team motivated and engaged in a highly regulated environment?I foster a culture of recognition by celebrating milestones and providing constructive feedback. I also encourage professional development through training opportunities and cross-training to broaden skills, which helps maintain morale and reduces burnout. Regulatory Affairs Supervisor – 40134 University Staff ## Description University of Colorado Anschutz Medical Campus Department: Cancer Center Working Title: Regulatory Affairs Supervisor Position #: 697586 – Requisition #: 40134 Job Summary: This position oversees their regulatory unit in the Cancer Clinical Trials Office (CCTO) and directly supervises their assigned regulatory unit staff. The Regulatory Research Supervisor ensures regulatory compliance for clinical research studies, provides leadership and mentorship to regulatory personnel, and collaborates with investigators, sponsors, and research teams to support the timely and compliant conduct of clinical trials. The position also contributes to quality assurance, process improvement, and operational initiatives while serving as a regulatory subject matter expert within the CCTO. Key Responsibilities: 50% Supervisory – Training/Mentorship/Workload Management · Assures adherence within their regulatory unit to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies. * Arranges orientation and provides training, supervision, and mentorship to their regulatory unit. * Supervises vacation, out of office coverage, and time management of direct reports. Makes recommendations regarding regulatory personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions with guidance from Regulatory Manager. This would include letters of expectations being written and delivered to direct reports. * Monitors workload acuity with guidance from the Regulatory Manager. · Assists regulatory specialists with technical issues, problem solving and intervention when appropriate. Answers questions from regulatory team including but not limited to processes, guidance documents, sponsor/ monitor questions, approval committee queries, and department logistics. · Ensures required timelines are met for submission, approval and distribution of protocol amendments, consent revisions and all applicable protocol specific documents for their regulatory unit. · Assures compliance with OnCore entries ensuring that accuracy is maintained. 40% Leadership/Compliance/Process Improvement * As part of the regulatory leadership team, collaborates with other Regulatory Supervisors and Regulatory Managers to identify team challenges, solutions, and improvement ideas. * Develops a firm understanding of institution/department policies and guidance documents, recommending updates as applicable. * Collaborates with Clinical Research Managers to ensure protocol amendments are processed in an efficient and timely manner. · Works closely with Regulatory Manager and CCTO Project Manager(s) to ensure protocol opening timelines and protocol opening policies are met and followed. · Actively participates in Regulatory team meetings and department meetings. This includes providing agenda items and discussion points. · Participates in external audits and internal process improvement strategies to promote consistent best practices. · Performs routine quality assurance audits on electronic regulatory binders within their regulatory unit as needed. 10% Regulatory Affairs Coordination and Coverage · May serve as regulatory contact and carry a regulatory workload as needed for team coverage and understanding of regulatory tasks and job functions. * Serves as back-up to staff absences, vacancies, within assigned regulatory unit or across regulatory team as needed. · Serves as back-up to Regulatory Manager if needed. Work Location: Hybrid – This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. You may be eligible to work a hybrid schedule after six months of employment. This benefit must be approved by your supervisor. In the event of departmental workload increase or special projects, you may be asked to report full-time on site until project completion. Why Join Us: The [University of Colorado Cancer Center](https://olucdenver-my.sharepoint.com/personal/brendon_bravo_cuanschutz_edu/Documents/Microsoft%20Teams%20Chat%20Files/University%20of%20Colorado%20Cancer%20Center) stands at the forefront of cancer research and patient care in Colorado. As the state’s only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: “prevent and conquer cancer. Together.” At the heart of our mission is the work to “unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education.” Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere. 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: 10/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](https://advantage.cu.edu/). To see what benefits are available, please visit: [https://www.cu.edu/employee-services/benefits-wellness](https://www.cu.edu/employee-services/benefits-wellness) Qualifications: Minimum Qualifications: Education: Bachelor’s degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment. Experience: Three (3) years of clinical research experience, with at least 2 of those 3 years in regulatory affairs. 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. Applicants must meet minimum qualifications at the time of application. 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. Preferred Qualifications: ● Two years Oncology research experience ● Experience with IRB, Ethics Committee ● Working knowledge of Advarra OnCore and Advarra eRegulatory platforms ● Experience with Sponsors and Audits ● Advance knowledge of ICH Guidelines, FDA and HIPAA Regulations ● Additional certification (one of the following): ● CCRC – Certified Clinical Research Coordinator ● CCRP – Certified Clinical Research Professional ● CCRA – Certified Clinical Research Associate Condition of Employment: Certification required within 1 year of hire (one of the below): ● CCRC – Certified Clinical Research Coordinator ● CCRP – Certified Clinical Research Professional ● CCRA – Certified Clinical Research Associate Knowledge, Skills and Abilities: ● Analytical Skills – Ability to interpret and master complex research protocol information. ● Attention to Detail – Excellent attention to detail and ability to interpret and master complex research protocol information ● Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions. ● Communication Skills – Good command of the English language, and ability to communicate effectively, both written and verbal. ● Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality. ● Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems. ● Adaptability – Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team. ● Planning and Organizing – Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks. ● Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology. ● Knowledge of and experience with basic human anatomy, physiology, and medical terminology. ● Intermediate to Advanced Microsoft Office skills (Excel, Word, Outlook). 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: Jatonya Turner: Jatonya.turner@cuanschutz.edu Screening of Applications Begins: Applications will be accepted until finalists are identified, but preference will be given to complete applications received by June 11, 2026. Those who do not apply by this date may or may not be considered. Anticipated Pay Range: The starting salary range (or hiring range) for this position has been established as HIRING RANGE) ($71,517 – $90,970). 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: [http://www.cu.edu/node/153125](http://www.cu.edu/node/153125) 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](mailto: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](https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf). 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](https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment). Application Materials Required: Cover Letter, Resume/CV, List of References ## Job Category : Research Services ## Primary Location : Aurora Department: U0001 — Anschutz Med Campus or Denver – 20066 – SOM-U of Colo Cancer Center ## Schedule : Full-time ## Posting Date : Jun 4, 2026 ## Unposting Date : Ongoing Posting Contact Name: Jatonya Turner Posting Contact Email: Jatonya.turner@cuanschutz.edu Position Number: 00697586 Show more [Apply now >](https://jobicy.com/jobs/145641-regulatory-affairs-supervisor.md) * ![Upload CV](data:image/svg+xml;base64,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) ### Upload your resume now To unlock remote work opportunities and be discovered by global employers. 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