Director, Regulatory Affairs – Advertising and Promotion

🔥 1 hour ago

☕ Washington – Remote

☕ Washington – Remote

💵 $222.9k - $310.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Immunome, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Immunome, Inc. is a clinical-stage oncology company dedicated to improving outcomes for cancer patients through the development of innovative therapeutic candidates. With a focus on targeted therapies, Immunome integrates rigorous scientific research to create first-in-class and best-in-class treatments. Their pipeline includes several promising drug candidates, including antibody drug conjugates and radioligand therapies aimed at addressing high unmet medical needs in oncology.

📋 Description

• Develop and execute the U.S. regulatory Advertising & Promotion strategy across the product lifecycle, from pre-launch planning through post-market execution • Provide strategic guidance on promotional positioning, claims, and evidence requirements aligned with approved labeling, clinical data, and internal standards • Serve 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 ensure consistent, timely, and compliant review of materials • Review and approve promotional labeling, advertising, and external communications for HCP and consumer audiences, including digital/social, congress, speaker programs, sales training, and other materials • Drive risk identification and mitigation plans; document regulatory rationale and provide feedback to stakeholders and agency partners • Oversee preparation, quality control, submission, tracking, records, and archives for promotional materials, including FDA Form 2253 submissions • Lead or support OPDP interactions involving promotional materials, advisory comments, information requests, and response development • Establish, maintain, and improve A&P policies, SOPs, templates, and review standards • Develop 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; advise leadership on emerging risks and opportunities • Build and mentor a high-performing A&P team • Partner with Commercial, Medical Affairs, Market Access, and Patient Advocacy teams on compliant communication strategies • Manage external agencies and vendors supporting promotional development

🎯 Requirements

• Pharm.D., Ph.D., M.S., or other advanced degree in life sciences or related field; B.S. with commensurate experience will be considered • Minimum 10+ years of Regulatory Affairs experience in the biopharmaceutical industry, with significant U.S. advertising and promotion review experience in oncology and product launch experience, or equivalent • Demonstrated experience leading regulatory review of promotional materials in an MLR environment, including omnichannel and digital/social communications • Strong knowledge of FDA advertising and promotion regulations, promotional submission requirements including FDA Form 2253, Subpart E/H, and related regulatory activities • Proven track record supporting product launches and lifecycle management, including pre-approval communications and early commercialization planning • Experience interacting with OPDP and managing responses to regulatory comments, advisory feedback, or enforcement actions • In-depth knowledge of U.S. promotional regulations, FDA/OPDP guidance, and current enforcement trends • Ability to translate scientific and clinical data into compliant claims and messaging frameworks, with strong risk-benefit assessment judgment • Leadership and influence skills to drive timely decisions and alignment across cross-functional stakeholders • Excellent written and verbal communication skills • Success developing, implementing, and improving A&P processes, SOPs, and training programs • Strong project management skills; ability to manage multiple products and competing priorities • Stakeholder management and conflict resolution skills • Experience managing and developing staff and external vendors/partners

🏖️ Benefits

• Remote work option within the U.S. • Equal opportunity and inclusive work environment