Senior Manager, Regulatory Affairs Advertising & Promotions

Overview The Senior Manager, Regulatory Affairs Advertising & Promotion is responsible for directing the regulatory aspects of internal and external communications including advertising and promotional activities. Responsibilities Bachelor's degree in a scientific discipline; advanced degree preferred.A minimum of 6 years of progressively responsible Regulatory Affairs experience with a focus on advertising and promotional regulations.Experience communicating and negotiating directly with OPDP and performing risk assessments.Significant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance of advertising and promotion materials.Experience with labeling development and life-cycle management.Experience with advertising and promotions on social media platforms and Direct-to-Consumer (DTC) knowledge strongly preferred.Strong knowledge of US regulatory environment and FDA regulations and guidance regarding advertising and promotional materials for Drugs, Biologics, and Medical Devices.Competencies: Strategic Leadership, Teamwork & Collaboration, Attention to Detail, Self-Starter, Negotiation skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skillsWorking Conditions Periodic overnight travel.This position is based in Xeris' Chicago office and requires a minimum of three days per week in the office.