Director, Regulatory Affairs – Advertising and Promotion

This is a fully remote position, open to applicants in Washington.

📋 Description

• Create and implement the U.S. regulatory Advertising & Promotion strategy throughout the product lifecycle, from initial launch planning to post-market execution.

• Offer strategic insights on promotional positioning, claims, and evidence requirements that align with approved labeling, clinical data, and internal standards.

• Act as the internal subject matter expert on FDA advertising and promotion regulations, guidance, OPDP enforcement trends, and best practices.

• Lead Immunome’s Medical-Legal-Regulatory committee to guarantee a consistent, timely, and compliant review of materials.

• Evaluate and authorize promotional labeling, advertising, and external communications aimed at healthcare professionals and consumers, including digital/social media, congress presentations, speaker programs, sales training, and other materials.

• Drive the identification of risks and develop mitigation plans; document regulatory rationale and offer feedback to stakeholders and agency partners.

• Oversee the preparation, quality control, submission, tracking, record-keeping, and archiving of promotional materials, including FDA Form 2253 submissions.

• Lead or assist with OPDP interactions concerning promotional materials, advisory comments, information requests, and response development.

• Establish, maintain, and enhance A&P policies, SOPs, templates, and review standards.

• Create and deliver training for cross-functional teams and vendors on promotional regulations, scientific exchange, and compliant communications.

• Monitor FDA guidance, industry trends, and enforcement actions; consult leadership on emerging risks and opportunities.

• Build and mentor a high-performing A&P team.

• Collaborate with Commercial, Medical Affairs, Market Access, and Patient Advocacy teams on compliant communication strategies.

• Manage external agencies and vendors involved in promotional development.

⛳️ Requirements

• Pharm.D., Ph.D., M.S., or another advanced degree in life sciences or a related field; a B.S. with equivalent experience will also be considered.

• At least 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry, specifically with substantial U.S. advertising and promotion review experience in oncology and product launch experience, or equivalent.

• Proven experience leading regulatory reviews of promotional materials in an MLR environment, including omnichannel and digital/social communications.

• Comprehensive knowledge of FDA advertising and promotion regulations, promotional submission requirements including FDA Form 2253, Subpart E/H, and related regulatory activities.

• Successful track record in supporting product launches and lifecycle management, including pre-approval communications and early commercialization planning.

• Experience engaging with OPDP and managing responses to regulatory comments, advisory feedback, or enforcement actions.

• Deep understanding of U.S. promotional regulations, FDA/OPDP guidance, and current enforcement trends.

• Ability to convert scientific and clinical data into compliant claims and messaging frameworks, coupled with strong risk-benefit assessment judgment.

• Leadership and influence capabilities to drive timely decisions and alignment among cross-functional stakeholders.

• Exceptional written and verbal communication skills.

• Proven success in developing, implementing, and enhancing A&P processes, SOPs, and training programs.

• Strong project management skills with the ability to juggle multiple products and competing priorities.

• Skills in stakeholder management and conflict resolution.

• Experience in managing and developing staff and external vendors/partners.

🏝️ Benefits

• Option for remote work within the U.S.

• Commitment to an equal opportunity and inclusive work environment.