Lead, Regulatory Operations (Remote)

The START Center for Cancer Research is seeking a Lead, Regulatory Operations (Remote) who will serve as the regulatory subject-matter expert (SME) and provides guidance, training, and operational oversight to the Regulatory Operations team. This role oversees complex regulatory submissions, supports process improvement initiatives, delegates and prioritizes work as needed, performs quality reviews to ensure compliance and accuracy. The Lead will prepare and submit regulatory documents for new and ongoing clinical studies to the Institutional Review Board (IRB), US Food and Drug Administration (FDA), and Institutional Biosafety Committee (IBC). This role requires strong problem-solving ability, sound judgment, and a high degree of independence. As team lead, ensure turnaround times are met, collect and review key metrics and continually improve processes to help achieve goals. This is a remote role. The salary range for this role is $80,000 - $105,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. Work Schedule: Monday-Friday 8:00am-5:00pm Essential 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. Required Education and Experience: • 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. Physical & Travel Requirements: • Sitting for extended periods of time. • Typing and computer use for extended periods of time. Best-in-Class Benefits and Perks We value our employees' time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including: • Comprehensive health coverage: Medical, dental, and vision insurance provided • Robust 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 • Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.