Senior Manager, Regulatory Operations at Immunome, Inc.

Bothell, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

189039.0

Posted On

04 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Operations, Project Management, Communication Skills, Collaboration, Attention to Detail, Regulatory Compliance, Document Management, eCTD Submissions, Oncology Development, Regulatory Frameworks, Publishing Tools, EDMS, RIM, SOP Development, Process Improvement, Risk Management

Industry

Biotechnology Research

Description

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. Position Overview The Senior Manager, Regulatory Operations will play a critical role in leading Immunome’s regulatory systems, submissions and documentation processes across our clinical-stage oncology programs. This individual will oversee regulatory information management, publishing, and operational activities to ensure high-quality, timely submissions that meet global regulatory requirements. 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. Qualifications 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. Experience supporting oncology development programs is preferred. Knowledge and Skills 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. Washington State Pay Range $167,216—$189,039 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

Responsibilities

The Senior Manager, Regulatory Operations will lead the planning, formatting, publishing, and submission of global regulatory documents. This role includes managing document workflows and ensuring compliance with global regulatory requirements.