Senior Manager, Regulatory Operations

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.

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).