Manager, Regulatory Operations
New
J
JobgetherOncology clinical research
Based in the United StatesFull-TimeManager
SalaryAnnual base salary: $110,000–$135,000. Eligibility for an annual performance bonus based on role and organizational results.
Apply NowOpens the employer's application page
Job Details
- Experience
- At least 5 years of progressively responsible experience in a regulatory research environment
- Required Skills
- JiraMicrosoft Office
Requirements
- Bachelor's degree or equivalent relevant professional experience in lieu of a degree.
- At least 5 years of progressively responsible experience in a regulatory research environment.
- Experience with new study submissions and ongoing regulatory document management.
- Demonstrated experience leading or supervising teams, coordinating workloads, and supporting employee development.
- Advanced working knowledge of IRB, FDA, and IBC requirements.
- Knowledge of Good Clinical Practice (GCP), FDA Bioresearch Monitoring (BIMO), and 21 CFR Part 11 requirements.
- Experience maintaining inspection-ready regulatory documentation and supporting audits or regulatory inspections.
- Proficiency with Microsoft Office and regulatory data-tracking or document-management systems such as Jira, Veeva, or Advarra E-Reg.
- Ability to collaborate with internal teams and external stakeholders, resolve complex regulatory issues, and drive continuous improvement.
- Availability to travel up to 10% of the time.
Responsibilities
- Lead, coach, and develop Regulatory Operations team members, overseeing workload allocation, study assignments, and team performance.
- Partner with Regulatory Operations leadership and Quality Assurance to set departmental goals and deliver regulatory milestones across the study lifecycle.
- Oversee accurate, complete, compliant, and timely regulatory submissions across assigned studies and sites.
- Develop and improve SOPs, work instructions, templates, and training materials.
- Manage relationships with IRBs, IBCs, sponsors, CROs, and other regulatory stakeholders.
- Oversee preparation and submission of study applications, consent documents, amendments, review reports, safety reports, and other required documentation.
- Coordinate assigned expanded access submissions to the FDA and manage follow-ups and regulatory inquiries.
- Maintain complete, accurate, inspection-ready Investigator Site Files throughout the study lifecycle.
- Monitor submission turnaround times, aging items, and quality findings, and implement corrective actions and process improvements.
- Coordinate study closeout visits and complete associated regulatory documentation and follow-up activities.
View Full Description & ApplyYou'll be redirected to the employer's site
