Immunome, Inc.

Director / Senior Director, Regulatory Affairs Advertising & Promotion

Bothell, Washington, United States · Director

Sponsorship not specifiedDetected 34 days ago

Product ManagementFDA RegulatoryLeadershipCommunicationCollaborationMentoringRegulatory Affairs

About the role

The successful candidate will bring deep expertise in FDA advertising and promotion regulations and OPDP practices, strong judgment and risk-based decision making, and proven leadership in medical-legal-regulatory review environments.

Develop and execute the U.S. regulatory Advertising & Promotion (A&P) strategy across the product lifecycle, from pre-launch planning through post-market execution.
Drive risk identification and mitigation plans
document regulatory rationale and provide clear, practical feedback to cross-functional stakeholders and agency partners.
Oversee preparation, quality control, and timely submission of promotional materials (e.g., FDA Form 2253 submissions) and maintain submission tracking, records, and archives.
Lead or support OPDP interactions related to promotional materials, advisory comments, requests for information, and response development in collaboration with Regulatory leadership and Legal.
Establish, maintain, and continuously improve A&P policies, SOPs, templates, and review standards to increase consistency and efficiency.
Drive risk identification and mitigation plans; document regulatory rationale and provide clear, practical feedback to cross-functional stakeholders and agency partners.
Develop and deliver training for cross-functional teams and vendors on promotional regulations, scientific exchange, and compliant communications.
Build and mentor a high-performing A&P team; set clear objectives, provide coaching, and foster a culture of collaboration and accountability.
Manage external agencies and vendors supporting promotional development, ensuring alignment with regulatory strategy, submission requirements, and compliance expectations.

Serve as the regulatory lead for Immunome's Medical-Legal-Regulatory (MLR) committee to ensure consistent, timely, and compliant review of materials.
Act as a strategic partner to Commercial, Medical Affairs, Market Access, and Patient Advocacy teams to enable effective, compliant communication strategies.
This role will partner with Commercial, Medical Affairs, Legal, and Compliance to enable compliant and competitive communication strategies from early launch planning through post-launch execution.

We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates.
We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

This listing is sourced directly from Immunome, Inc.'s careers page and normalized into a canonical job model.