Note: The job is a remote job and is open to candidates in USA. The START Center for Cancer Research is seeking a Lead, Regulatory Operations to provide subject-matter expertise, guidance, training, and operational oversight for its Regulatory Operations team. The role manages complex regulatory submissions for clinical studies, ensures quality and compliance, and leads process improvement across START USA sites.
Responsibilities
- Ensure turn around times are met and actively seek ways to enhances processes to ensure departmental goals are consistently achieved
- Prepare and submit new study applications and amendments to the IRB, including drafting and negotiating informed consent forms (ICFs) with Sponsors/CROs
- Serve as the primary point of contact for assigned studies with the IRB, IBC, and FDA
- Prepare and submit regulatory documents including revised protocols, investigator brochures, safety reports, deviations, clarifications, continuing review reports, and closure documents
- Prepare and submit Expanded Access and other complex or high‑risk study submissions to the FDA
- Track all submissions in FileMaker or applicable systems and maintain accurate status updates
- Maintain complete, accurate, and audit‑ready Investigator Site Files (ISF), both paper and electronic
- Lead and manage regulatory close‑out responsibilities for assigned studies
- Train, mentor, and support Regulatory Operations team members, ensuring accurate submissions and proper regulatory filing
- Perform quality control (QC) reviews of submissions and regulatory documents prepared by staff
- Assist in work prioritization, workflow management, and cross‑functional coordination
- Serve as the escalation point for complex regulatory questions or study challenges
- Attend and represent Regulatory Operations in weekly Phase I meetings, Protocol Review, and Site Initiation Visits
- Collaborate with other departments to resolve regulatory issues and ensure timely submission of deliverables
- Develop, revise, and implement Work Instructions and SOPs
- Assist with regulatory file preparation for audits and inspections; participate in CAPA development
- Partner with leadership to improve regulatory processes, systems, and standardization across START USA sites
Skills
- Bachelor's degree or equivalent experience
- Minimum 5–7 years of regulatory experience in clinical research, including new study submissions
- Leading, training, onboarding direct reports with previous supervisory experience
- Advanced knowledge of IRB, IBC, and FDA submission requirements
- Proficiency with Microsoft Word and FileMaker Pro (or similar regulatory tracking systems)
- Exceptional organizational skills with attention to detail, accuracy, and completeness
- Ability to independently manage multiple priorities, deadlines, and complex tasks
Benefits
- Medical, dental, and vision insurance provided
- 401(k) plan available with employer matching
- Life and disability insurance for added protection
- Health savings and flexible spending accounts offered
- Paid time off
- Flexible schedule
- Remote work choices provided
- A collaborative, creative environment where everyone feels encouraged to contribute to processes, decisions, planning, and culture
- Opportunities to learn and grow with the company
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