Remote Regulatory Startup Manager

Fred Hutchinson Cancer Center (Fred Hutch); Seattle (WA); Remote; USD 99,000 - 157,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid time off

Tuition reimbursement

Onsite health clinic

Job summary

Fred Hutchinson Cancer Center in Seattle, WA, invites applications for Startup Regulatory Operations Manager, responsible for overseeing regulatory startup activities to activate clinical studies. You will coordinate documentation, trainings, and regulatory submissions, serving as liaison among investigators, sponsors, IRBs, regulators, and study teams.

The role leads regulatory processes, ensures compliance with FDA, ICH-GCP, and institutional policies, and drives startup timelines.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• 5+ years of clinical research experience, including regulatory operations and startup.
• At least 2 years in leadership or supervision.
• Experience with regulatory submissions, IRBs, sponsors, and FDA regulations.
• Strong project management and organizational skills.
• Excellent verbal and written communication skills.

Responsibilities

• Lead regulatory startup and activation activities for multiple studies and ensure documentation, approvals, and training are in place.
• Monitor milestones, identify risks, and implement mitigations to meet activation timelines.
• Ensure regulatory compliance through review of protocols, consents, and essential documents, and support audits.
• Develop regulatory startup strategies and drive process improvements for efficiency.
• Act as primary regulatory liaison to investigators, sponsors, CROs, and stakeholders.
• Coach and develop regulatory staff and manage workload and performance.

Skills

Leadership experience

Project management

Regulatory knowledge

Communication skills

Education

Bachelor's degree or equivalent

Tools

FDA regulations

GCP compliance

IRB coordination

CTMS/eBinders familiarity

Job description

Fred Hutchinson Cancer Center in Seattle, WA, invites applications for Startup Regulatory Operations Manager, responsible for overseeing regulatory startup activities to activate clinical studies. You will coordinate documentation, trainings, and regulatory submissions, serving as liaison among investigators, sponsors, IRBs, regulators, and study teams.

The role leads regulatory processes, ensures compliance with FDA, ICH-GCP, and institutional policies, and drives startup timelines.