Regulatory Affairs Supervisor

Regulatory Affairs Supervisor

Company: University of Colorado Anschutz Medical Campus Department: Cancer Center Location: Aurora, USA (Onsite) Contract: Permanent Schedule: Full-time

The University of Colorado Cancer Center is seeking a dedicated and experienced Regulatory Affairs Supervisor to oversee their regulatory unit within the Cancer Clinical Trials Office (CCTO). This is an exciting opportunity to join a leading institution at the forefront of cancer research and patient care, contributing to the mission of preventing and conquering cancer.

About the Role

The Regulatory Affairs Supervisor will be responsible for leading and managing a regulatory unit, ensuring compliance with all relevant regulations for clinical research studies. This role involves direct supervision of regulatory staff, providing mentorship, and fostering a collaborative environment to support the efficient and compliant conduct of clinical trials. You will serve as a subject matter expert, contributing to quality assurance, process improvement, and operational initiatives within the CCTO.

Key Responsibilities

• Supervision and Team Management (50%):
  • Oversee the regulatory unit, ensuring adherence to standards set by the FDA, OHRP, NCI, and other regulatory bodies.
  • Provide training, supervision, and mentorship to regulatory unit staff.
  • Manage workload, time, and coverage for direct reports.
  • Participate in hiring decisions, performance evaluations, and disciplinary actions with guidance from the Regulatory Manager.
  • Assist regulatory specialists with technical issues and problem-solving.
  • Ensure timely submission, approval, and distribution of protocol amendments, consent revisions, and other required documents.
  • Maintain accuracy of OnCore entries.
• Leadership, Compliance, and Process Improvement (40%):
  • Collaborate with regulatory leadership to identify team challenges and implement solutions.
  • Develop a strong understanding of institutional policies and recommend updates.
  • Work with Clinical Research Managers to ensure efficient processing of protocol amendments.
  • Ensure adherence to protocol opening timelines and policies.
  • Actively participate in team and department meetings, contributing agenda items and discussion points.
  • Participate in internal and external audits and quality assurance initiatives.
  • Conduct routine quality assurance audits of electronic regulatory binders.
• Regulatory Affairs Coordination and Coverage (10%):
  • Serve as a regulatory contact and manage a regulatory workload as needed.
  • Provide backup support for staff absences and vacancies within the regulatory team.
  • Act as backup to the Regulatory Manager when required.

Requirements

• Bachelor’s degree in business, health administration, communications, biological or social science, or a related field (or equivalent combination of education and experience).
• Three (3) years of clinical research experience, with at least two (2) years in regulatory affairs.
• Strong understanding of regulatory standards set forth by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), National Cancer Institute (NCI), and other relevant agencies.
• Excellent analytical, problem-solving, and communication skills.
• Ability to establish and maintain effective working relationships and demonstrate strong interpersonal and customer service skills.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Ability to work independently and as part of a team, managing multiple priorities effectively.

Preferred Qualifications

• Two years of oncology research experience.
• Experience with Institutional Review Boards (IRBs) and Ethics Committees.
• Working knowledge of Advarra OnCore and Advarra eRegulatory platforms.
• Experience with sponsors and audits.
• Advanced knowledge of ICH Guidelines, FDA, and HIPAA Regulations.
• Relevant professional certification (CCRC, CCRP, or CCRA).

What We Offer

• Competitive Salary: Hiring range of $71,517 - $90,970.
• Exceptional Benefits Package:
  • Medical and Dental insurance (multiple plan options).
  • Additional insurance options (Disability, Life, Vision).
  • Retirement 401(a) Plan with a 10% employer contribution.
  • Generous Paid Time Off: 22 vacation days and 15 sick days per year.
  • 10 paid holidays per year.
  • Tuition benefit for employees.
  • ECO Pass for reduced-rate public transportation.
• Work Environment: Join a prestigious National Cancer Institute (NCI) designated Comprehensive Cancer Center dedicated to groundbreaking research and patient care.
• Hybrid Work Model: Eligible for a hybrid schedule after six months of employment, subject to supervisor approval and departmental needs.

Application Materials Required: Cover Letter, Resume/CV, List of References.

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