Director of Regulatory Affairs

Director, Regulatory Affairs Advertising & Promotion Position Summary We are seeking a highly experienced and strategic Director, Regulatory Affairs Advertising & Promotion (A&P) to provide regulatory leadership and oversight for promotional and non-promotional communications across a portfolio of innovative pharmaceutical products. This individual will serve as a key partner to Commercial, Medical Affairs, Legal, Compliance, and Marketing teams, ensuring that all communications are scientifically accurate, balanced, compliant with applicable regulations, and aligned with corporate objectives. The Director will play a critical role in shaping promotional strategy, guiding cross-functional teams through complex regulatory considerations, and fostering a culture of compliance while enabling business objectives. This position offers the opportunity to influence high-visibility initiatives supporting both established brands and future product launches. Key Responsibilities Provide strategic regulatory guidance and oversight for promotional and medical communications across marketed products and pipeline assets. Review and approve advertising, promotional, digital, social media, speaker program, patient education, and disease awareness materials to ensure compliance with FDA regulations, industry standards, and internal policies. Serve as the Regulatory Affairs Advertising & Promotion representative on cross-functional brand teams, launch teams, and promotional review committees. Partner closely with Commercial, Medical Affairs, Legal, Compliance, Corporate Communications, and Market Access teams to support development of compliant and effective promotional strategies. Interpret and communicate regulatory requirements related to prescription drug promotion, including FDA regulations, guidance documents, and enforcement trends. Advise stakeholders on risk assessment, claim substantiation, fair balance, and promotional messaging. Support regulatory strategy and review of product launch materials, lifecycle management initiatives, and new indications. Monitor FDA enforcement actions, warning letters, untitled letters, and industry developments to proactively inform promotional practices. Lead interactions related to promotional submissions and regulatory inquiries as needed. Develop and deliver training programs to commercial and cross-functional teams on advertising and promotion regulations and best practices. Contribute to the enhancement of internal review processes, governance structures, and compliance frameworks. Provide mentorship and leadership to regulatory colleagues and support organizational development initiatives. Qualifications Required Bachelor's degree in a scientific, healthcare, or related discipline. 10+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry. 5+ years of direct experience supporting Advertising & Promotion regulatory activities for prescription pharmaceutical products. Deep knowledge of FDA promotional regulations, OPDP requirements, FDA guidance documents, and industry best practices. Experience reviewing a broad range of promotional materials, including print, digital, social media, speaker programs, websites, patient-facing materials, and field force communications. Demonstrated ability to influence cross-functional stakeholders and navigate complex business environments. Strong understanding of pharmaceutical product lifecycle management and commercial operations. Excellent communication, presentation, negotiation, and leadership skills. Preferred Advanced degree (PharmD, PhD, MS, JD, MPH, or equivalent). Experience supporting neuroscience, psychiatry, addiction medicine, CNS, or specialty pharmaceutical products. Experience supporting product launches and post-launch commercial activities. Prior participation in Promotional Review Committees (PRCs) or Medical, Legal, Regulatory (MLR) review processes. Experience interacting directly with FDA Office of Prescription Drug Promotion (OPDP). Strategic Regulatory Leadership Advertising & Promotion Expertise Risk Assessment and Decision Making Cross-Functional Collaboration Executive Presence and Influence Regulatory Compliance and Governance Communication and Stakeholder Management Commercial Business Acumen Success Profile The ideal candidate is a proactive and solutions-oriented regulatory leader who understands how to balance compliance with business objectives. They possess deep expertise in pharmaceutical advertising and promotion regulations, strong commercial acumen, and the ability to build productive partnerships across the organization. This individual will be a trusted advisor to senior leadership and a key contributor to the successful commercialization and lifecycle management of innovative therapies. #J-18808-Ljbffr Green Key Resources