Director, Advertising and Promotion Regulatory Affairs

Job Responsibilities

Promotional Review Committee and Governance

• Participate actively in PRC meetings and Veeva PromoMats workflows, providing timely, clear, and documented regulatory comments and decisions.
• Partner with Medical and Legal reviewers to resolve comments, align on compliant alternatives, and escalate material regulatory risks through established governance when needed.
• Provide regulatory leadership for launch readiness, including development of core claims, launch materials, field training, websites, congress materials, speaker program materials, digital communications, and patient or caregiver materials.
• Support the development and maintenance of PRC procedures, standards, job aids, review criteria, and governance practices.
• Promote consistent application of regulatory standards across brands, channels, audiences, and material types.

Regulatory Submissions and Compliance

• Lead or oversee the regulatory assessment, preparation, quality review, and submission of promotional materials to FDA, including Form FDA 2253 submissions, as applicable.
• Coordinate with Regulatory Operations and the PRC Coordinator to ensure required Health Authority submissions are completed and documented before distribution, when applicable.
• Monitor FDA guidance, policy developments, enforcement letters, advisory comments, and industry trends that may affect RayzeBio communications.
• Communicate labeling changes and emerging regulatory expectations that may require revision, reapproval, withdrawal, or replacement of promotional materials.
• Support responses to Health Authority inquiries involving advertising, promotional labeling, or product communications.

Cross-Functional Partnership and Leadership

• Advise Commercial, Medical Affairs, Market Access, Legal, Compliance, Corporate Communications, and other stakeholders during early concept development and throughout the material lifecycle.
• Balance regulatory risk, scientific support, intended audience, and business objectives while maintaining high standards for compliance and patient protection.
• Develop and deliver training on advertising and promotion requirements, PRC expectations, FDA enforcement trends, product labeling, and compliant communication principles.
• Coach and mentor Regulatory Affairs colleagues who support promotional review activities.
• Represent Regulatory Affairs in cross-functional launch, brand, and governance forums and communicate complex regulatory considerations to senior leaders.

Education and Experience

• Bachelor's degree or higher in life sciences, pharmacy, health sciences, or a related field; an advanced scientific, legal, or regulatory degree is preferred.
• Approximately 8 or more years of pharmaceutical or biotechnology Regulatory Affairs experience, including substantial hands-on experience in U.S. advertising and promotion regulatory review.
• Equivalent combinations of education and relevant experience may be considered.
• Demonstrated experience serving as a Regulatory Reviewer in a promotional review, medical-legal-regulatory, or comparable governance process.
• Strong working knowledge of FDA advertising and promotion requirements, prescription drug labeling, promotional labeling, and relevant FDA guidance and enforcement practices.
• Experience supporting product launch and lifecycle communications is strongly preferred.
• Oncology, specialty product, and/or radiopharmaceutical experience is preferred.
• Experience with Veeva PromoMats or a comparable promotional material review and approval system is preferred.

Skills and Qualifications

• Strategic and pragmatic regulatory judgment, with the ability to identify material risk and recommend compliant alternatives.
• Excellent written and verbal communication skills, including the ability to explain complex regulatory requirements clearly and concisely.
• Strong influence, negotiation, and conflict-resolution skills in a cross-functional and matrixed environment.
• Ability to make timely, well-reasoned decisions and operate effectively when precedent or guidance is evolving.
• Highly organized, with the ability to manage multiple reviews, priorities, and deadlines in a fast-paced environment.
• Meticulous attention to detail, including review of copy, data presentation, visual context, references, and required risk information.
• Demonstrated leadership, professionalism, sound ethics, and integrity.
• Proficiency in Microsoft Office, Microsoft Teams, and electronic review and approval systems.