Head of Global Regulatory Advertising and Promotion job opportunity at Sobi.

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Date2026-03-25T13:02:48.072Z bot
Sobi Head of Global Regulatory Advertising and Promotion
Experience: General
Pattern: Full-time
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degreeGeneral
loacation Waltham, Massachusetts, United States
loacation Waltham, Massa..........United States
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Job DescriptionThe Head of Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Policy, Intelligence and Advertising & Promotion, be a core member of the GRA Extended Leadership Team (ELT), and have accountability for 6 or more direct reports.  This role is responsible for leading and directing post-marketing regulatory activities pertaining to marketing of Sobi products, including regulatory review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s), submission to FDA OPDP/APLB, and be the owner of the Sobi Global Material review process.The role is responsible for leading interactions with the FDA Office of Product Prescription and Drug Promotion be responsible to function as a leader during review and escalation meetings to assure compliance with and evolution of the applicable Review process enabling business needs to be met in a compelling, compliant, and timely way.This position requires frequent interaction and strong collaboration with cross-functional partners for the purpose of providing regulatory advice and guidance throughout the product life cycle assuring conformity with applicable laws, regulations and Sobi policies.Provides vision, strategy and leads the adpromo team reporting into themDevelops and leads departmental strategic initiativesServe as strategic partner to internal leadership on regulatory risk assessment and mitigationOversees and directs the adpromo team in assessing regulatory context and provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedentsDemonstrate leadership as the Regulatory Advertising and Promotion LeaderBusiness owner of the Global Review ProcessProvides regulatory advice and guidance on Advertising and Promotion for Global promotional and non-promotional materialsServes as an internal subject matter expert on FDA Advertising & Promotion issues providing regulatory advice and offering solutions to regulatory concerns on draft promotional materials to ensure compliance with FDA regulationsLead interactions with OPDP/APLB, including proactive engagement with OPDP/APLB in support of business needs, and as needed, response to regulatory inquiries.Foster a healthy business partnership environment with cross-functional stakeholders to ensure company meets strategic business objectivesProvides regulatory training as needed on applicable laws, regulations and Sobi policiesDemonstrate leadership as the regulatory reviewer on Review Committees (RCs)Lead development of SOPs and Work Instructions to drive compliance through streamlined workflows and efficient execution of relevant processes

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