The Senior Manager of Regulatory Advertising and Promotions reports to the Executive Director of Regulatory Affairs and will manage the development and review of advertising and promotional information of the company’s marketed products.
This position will also have an opportunity to provide regulatory support to clinical and non-clinical regulatory activities as needed.PRIMARY JOB FUNCTIONSServes as a regulatory advertising and promotion reviewer on cross-functional Promotional Review Committee (PRC) and Medical Review Committees (MRCs)Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risksIdentifies and provides guidance on the development and improvement of policies, processes, and standards for promotional materials and related activitiesMaintains a deep and current awareness of evolving FDA and OPDP regulations and interpretations, advisory comments, enforcement actions and policy issues; Effectively partners with Medical Affairs, Legal Compliance, Commercial and International Distributors, as needed, to ensure promotional labeling, advertisements and educational materials are reviewed in a timely fashion throughout the product life-cycleAssists Commercial with the planning and prioritization of proposed promotional and disease state materials; provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achievedIn collaboration with global regulatory operations, ensures the management and maintenance of records and databases that support communication with OPDPDelivers Regulatory compliance training to assigned teams in preparation for scientific conferences on and off-siteIdentifies and escalates any unresolved regulatory affairs compliance concernsProvides oversight to relevant external vendors and consultantsBachelor’s degreeMust have knowledge and experience in global drug development, global regulations and guidelines and GXPs5 or more years of experience in advertising and promotions in a drug development environmentExperience and knowledge in oncology, cardiovascular disease, neurological and metabolic diseases strongly preferredAbility to work collaboratively and productively in a diverse, continually changing and team-oriented organizationAbility to work independently with internal and external stakeholders at various levelsExcellent organizational, facilitation and communication skillsSelf-motivated and able to work from a home office environmentDemonstrated leadership capabilities and proactive problem-solverPractical knowledge of MS Word, Excel, PowerPoint, and project management softwareOTHER REQUIREMENTSThis role can be performed remotely from a home office in the US.Some long-distance travel (10%) may be required with a potential of travel occurring over weekends.Flexible approach to time management with occasional work in evenings or over weekends as required.