Director, Advertising and Promotion Regulatory Affairs

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $210.6k - $255.2k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Provide regulatory leadership for U.S. promotional and commercial communications • Serve as a senior Regulatory Reviewer on the Promotional Review Committee (PRC) • Participate in PRC meetings and Veeva PromoMats workflows • Partner with Medical and Legal reviewers to resolve comments and escalate material regulatory risks • Lead regulatory support for launch readiness, including claims, launch materials, field training, websites, congress materials, speaker programs, digital communications, and patient or caregiver materials • Support PRC procedures, standards, job aids, review criteria, and governance practices • Lead or oversee regulatory assessment, preparation, quality review, and FDA submission of promotional materials, including Form FDA 2253 submissions • Coordinate Health Authority submissions with Regulatory Operations and the PRC Coordinator • Monitor FDA guidance, policy developments, enforcement letters, advisory comments, and industry trends • Communicate labeling changes and emerging regulatory expectations affecting promotional materials • Support responses to Health Authority inquiries • Advise Commercial, Medical Affairs, Market Access, Legal, Compliance, Corporate Communications, and other stakeholders throughout the material lifecycle • 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 • Represent Regulatory Affairs in cross-functional launch, brand, and governance forums • Communicate complex regulatory considerations to senior leaders

🎯 Requirements

• Bachelor's degree or higher in life sciences, pharmacy, health sciences, or a related field • 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 • Strategic and pragmatic regulatory judgment, including ability to identify material risk and recommend compliant alternatives • Excellent written and verbal communication skills • Strong influence, negotiation, and conflict-resolution skills in a cross-functional and matrixed environment • Ability to make timely, well-reasoned decisions while guidance is evolving • Ability to manage multiple reviews, priorities, and deadlines in a fast-paced environment • Meticulous attention to detail, including 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

• Additional discretionary incentive cash and stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) for U.S.-based exempt employees • 11 paid company holidays each year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • 3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year • Summer hours flexibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs • Annual Global Shutdown between Christmas Day and New Year's Day • Reasonable workplace accommodations/adjustments and ongoing support for people with disabilities

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