Remote Lead, Regulatory Operations - Oncology

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 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