Director Regulatory Affairs, Advertising and Promotion at Aimmune...

Summary Reporting to the VP, North America Regulatory Affairs the Director, Regulatory Affairs Advertising and Promotion will manage regulatory strategy, and material approvals for areas of responsibility and ensure these activities are consistent with the overall company strategy. A crucial part of this role is ensuring strong coordination and collaboration across internal departments and stakeholders including the Clinical, Commercial, Medical Affairs, Pharmacovigilance, and Compliance organizations. Responsibilities: Guide, direct and coordinate the strategic advertising/promotion and MRL planning for company products from a... regulatory perspective for pre and post launch campaigns Maintain oversight and efficiency of systems for managing review and approval of non-promotional (MRL) and/or advertising and promotional materials Provide input into or develop required processes, including transitioning of acquired products into company systems and associated standard operating procedures to ensure consistency of approach and regulatory compliance for areas of responsibility Manage regulatory affairs advertising and promotion/MRL staff members and provide direction on business milestones and timelines Perform routine process check and incorporate better practices as continuous process improvements for commercial products and processes Train, mentor, and develop direct reports and other internal staff as appropriate Apply critical review skills and creative solutions to diverse promotional and MRL scenarios Develop and maintain relationships with the FDA (OPDP, APLB, Office of Compliance) on advertising and promotional labeling-related activities Ensure that advertising and promotional, MRL and labeling materials meet FDA and Aimmune standards for assigned products Ensure promotional regulatory activities support business needs while appropriately mitigating promotional risk Survey, evaluate and interpret regulatory requirements relative to advertising and promotional labeling and disseminate information on impact of changes to appropriate stakeholders Provide relevant input into development or update of product labeling, upon request Preferred Experience, Special Skills, Knowledge: BS in relevant degree; an advanced degree is preferred. Experience in reviewing and approving advertising and promotion as well as non-promotional materials within a complex specialty/branded commercial pharmaceutical organization. Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly in North America.