Lead, Regulatory Operations (Remote)

Essential Responsibilities

• Ensure turn around times are met and actively seek ways to enhance 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.

Required Education And Experience

• Bachelor’s degree or equivalent experience.
• Minimum 5–7 years of regulatory experience in clinical research, including new study submissions.
• 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.

Physical & Travel Requirements

• Sitting for extended periods of time.
• Typing and computer use for extended periods of time.

Best-in-Class Benefits and Perks

• Comprehensive health coverage: Medical, dental, and vision insurance provided.
• Rothvest retirement planning: 401(k) plan available with employer matching.
• Financial security: Life and disability insurance for added protection.
• Flexible financial options: Health savings and flexible spending accounts offered.
• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided.

About The START Center for Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.