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Immunome, Inc. · 2 days ago

Senior Manager, Regulatory Operations

Bothell, Washington, United States

Full-time

Onsite

Senior Level

$167K/yr - $189K/yr

5+ years exp

Immunome is a clinical-stage targeted oncology company dedicated to developing innovative cancer therapies. The Senior Manager, Regulatory Operations will lead regulatory systems and submission processes for clinical-stage oncology programs, ensuring compliance with global regulatory requirements.

BiopharmaBiotechnologyMedicalPharmaceutical

Responsibilities

Lead the planning, formatting, publishing, and submission of global regulatory documents, including INDs, amendments, annual reports, meeting packages, and eCTD submissions

Manage document workflows, version control, and archival processes to maintain complete and compliant regulatory records

Partner with cross-functional teams to ensure timely delivery of submission components and adherence to regulatory standards

Oversee regulatory submission timelines, identifying risks and implementing mitigation strategies

Maintain and enhance regulatory systems, including EDMS, RIM, and publishing tools

Coordinate Health Authority meeting logistics and regulatory documentation

Support development of SOPs, templates, and process improvements

Ensure submissions comply with FDA, EMA, ICH, and other global regulations

Qualification

Regulatory operations experienceECTD submissionsRegulatory publishing toolsGlobal regulatory frameworksOncology development programsProject managementCommunication skillsCollaborationDetail-oriented

Required

Bachelor's degree in a scientific or related discipline is required

A minimum of 5 years of regulatory operations experience in the biotechnology or pharmaceutical industry

Demonstrated experience preparing and publishing eCTD submissions

Strong understanding of global regulatory frameworks and submission standards

Expertise with regulatory publishing tools and regulatory information management systems

Strong organizational, project management, and communication skills

Proven ability to collaborate effectively across functional teams

Detail-oriented with a commitment to high-quality documentation and compliance

Preferred

Experience supporting oncology development programs is preferred

Company

Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

Founded in 2008

Exton, Pennsylvania, USA

51-200 employees