Lead, Regulatory Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the regulatory subject-matter expert, providing guidance, training, and operational oversight to the Regulatory Operations team.

• Manage complex regulatory submissions and support initiatives for process improvement.

• Delegate tasks and prioritize work as necessary.

• Conduct quality reviews to ensure compliance and accuracy.

• Prepare and submit regulatory documents for both new and ongoing clinical studies to the IRB, FDA, and IBC.

• Ensure adherence to turnaround times while continuously improving processes to meet departmental objectives.

• Prepare and submit new study applications and amendments to the IRB, including drafting and negotiating informed consent forms with Sponsors/CROs.

• Serve as the main 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 using FileMaker or relevant systems, ensuring accurate status updates are maintained.

• Maintain complete, accurate, and audit-ready Investigator Site Files in both paper and electronic formats.

• Lead and manage regulatory close-out responsibilities for assigned studies.

• Train, mentor, and support members of the Regulatory Operations team.

• Conduct quality control reviews of submissions and regulatory documents prepared by staff.

• Assist with prioritizing work, managing workflow, and coordinating across functions.

• Act as the escalation point for complex regulatory inquiries or study challenges.

• Attend and represent Regulatory Operations in weekly Phase I meetings, Protocol Review, and Site Initiation Visits.

• Collaborate with other departments to address regulatory issues and ensure timely delivery of required submissions.

• Develop, revise, and implement Work Instructions and Standard Operating Procedures (SOPs).

• Assist in preparing regulatory files for audits and inspections, and participate in the development of Corrective and Preventive Actions (CAPA).

• Partner with leadership to enhance regulatory processes, systems, and standardization across START USA sites.

⛳️ Requirements

• Bachelor’s degree or equivalent experience.

• A minimum of 5–7 years of regulatory experience in clinical research, including new study submissions.

• Previous supervisory experience in leading, training, and onboarding direct reports.

• Advanced understanding of IRB, IBC, and FDA submission requirements.

• Proficiency in Microsoft Word and FileMaker Pro or similar regulatory tracking systems.

• Exceptional organizational skills with a focus on detail, accuracy, and completeness.

• Ability to independently manage multiple priorities, deadlines, and complex tasks.

• Capability to sit for extended periods.

• Ability to type and use a computer for extended durations.

🏝️ 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 options.

• Collaborative, creative work environment.

• Opportunities for learning and growth.