[Hiring] Director of Advertising and Promotion Regulatory Affairs @Bristol Myers Squibb

Role Description

RayzeBio, a Bristol Myers Squibb company, is seeking an experienced and strategic Director of Advertising and Promotion Regulatory Affairs. This role will provide regulatory leadership for U.S. promotional and commercial communications and serve as a senior Regulatory Reviewer on the Promotional Review Committee (PRC). The Director will partner with Commercial, Medical Affairs, Legal, Compliance, Market Access, Corporate Communications, and Regulatory Operations to enable compliant, accurate, balanced, and effective communications for RayzeBio products and disease states.

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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.