Lead, Regulatory Operations

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $80k - $105k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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The START Center for Cancer Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

The START Center for Cancer Research is a global clinical research organization focused on early-phase oncology trials and advancing cancer therapies. START operates large, world-class research facilities across the United States and Europe and runs programs (such as the START Hope Hub) to help patients and families find, understand, and enroll in clinical trials. START serves patients, referring physicians, hospitals and oncology practices, and pharmaceutical partners, emphasizing broad access to clinical trials and translational cancer research.

📋 Description

• Serve as the regulatory subject-matter expert and provide guidance, training, and operational oversight to the Regulatory Operations team • Oversee complex regulatory submissions and support process improvement initiatives • Delegate and prioritize work as needed • Perform quality reviews to ensure compliance and accuracy • Prepare and submit regulatory documents for new and ongoing clinical studies to the IRB, FDA, and IBC • Ensure turnaround times are met and continually improve processes to achieve departmental goals • Prepare and submit new study applications and amendments to the IRB, including drafting and negotiating informed consent forms with Sponsors/CROs • Serve as the primary point of contact for assigned studies with the IRB, IBC, and FDA • Prepare and submit 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 submissions in FileMaker or applicable systems and maintain accurate status updates • Maintain complete, accurate, and audit-ready Investigator Site Files in paper and electronic formats • Lead and manage regulatory close-out responsibilities for assigned studies • Train, mentor, and support Regulatory Operations team members • Perform quality control reviews of submissions and regulatory documents prepared by staff • Assist with 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 and participate in CAPA development • Partner with leadership to improve regulatory processes, systems, and standardization across START USA sites

🎯 Requirements

• Bachelor’s degree or equivalent experience • Minimum 5–7 years of regulatory experience in clinical research, including new study submissions • Previous supervisory experience leading, training, and onboarding direct reports • 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 • Ability to sit for extended periods of time • Ability to type and use a computer for extended periods of time

🏖️ Benefits

• Medical, dental, and vision insurance • 401(k) plan with employer matching • Life and disability insurance • Health savings and flexible spending accounts • Paid time off • Flexible schedule • Remote work choices • Collaborative, creative work environment • Learning and growth opportunities