Lead, Regulatory Operations (Remote)

The START Center for Cancer Research; United States; Remote; USD 80,000 - 105,000; Full time

Benefits offered by this job

Health coverage

401(k) plan with employer matching

Life and disability insurance

Health savings and flexible spending

Paid time off and flexible schedule

Job summary

The START Center for Cancer Research seeks a Lead, Regulatory Operations (Remote) to guide the Regulatory Operations team, oversee complex submissions to IRB, FDA, and IBC, and drive process improvements. The role requires strong problem-solving, judgment, and independence.

As team lead, you will ensure timely submissions, train staff, review quality, and collaborate with cross-functional groups across START USA sites while supporting policy development and SOPs.

Qualifications

• Bachelor’s degree or equivalent experience required.
• 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.

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

Regulatory operations

Leadership

IRB submissions

FDA submissions

Education

Bachelor’s degree or equivalent experience

Tools

FileMaker Pro

Microsoft Word

Job description

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval.

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

Benefits

• 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.

More 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.

Learn more at STARTresearch.com.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.