Director, Advertising and Promotion Regulatory Affairs

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

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.

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.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment

The noise level in the work environment is usually moderate.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

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.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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