Lead, Regulatory Operations (Remote)

START Research; United States; Remote; USD 80,000 - 105,000; Full time

Benefits offered by this job

Health coverage

401(k) with employer matching

Life and disability insurance

Health savings & flexible spending

Paid time off & flexible schedule

Remote work options

Job summary

The START Center for Cancer Research seeks a Lead, Regulatory Operations (Remote) to serve as the regulatory SME and provide guidance, training, and operational oversight to the Regulatory Operations team. This role leads complex regulatory submissions and ensures timely, compliant processes across IRB, IBC, and FDA interactions.

The position is remote with a salary range of $80,000–$105,000 and requires a Bachelor’s degree or equivalent and 5–7 years of regulatory experience in clinical

Qualifications

• 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.

Responsibilities

• Oversee complex regulatory submissions, support process improvements, delegate and prioritize work.
• Prepare and submit regulatory documents for new and ongoing clinical studies to IRB, FDA, and IBC.
• Lead and mentor Regulatory Operations team members; ensure accurate submissions.
• Perform QC reviews of submissions and regulatory documents prepared by staff.
• Attend and represent Regulatory Operations in weekly Phase I meetings and site visits.
• Develop, revise, and implement Work Instructions and SOPs; support regulatory audits.

Skills

Regulatory leadership

Training & mentoring

Quality oversight

Problem solving

Education

Bachelor’s degree or equivalent

Tools

Microsoft Word

FileMaker Pro

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

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.

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.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide.

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.