Responsibilities

• Provides vision, strategy and leads the adpromo team reporting into them
• Develops and leads departmental strategic initiatives
• Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation
• Oversees and directs the adpromo team in assessing regulatory context and provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedents
• Demonstrate leadership as the Regulatory Advertising and Promotion Leader
• Business owner of the Global Review Process
• Provides regulatory advice and guidance on Advertising and Promotion for Global promotional and non-promotional materials
• Serves 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 regulations
• Lead 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 objectives
• Provides regulatory training as needed on applicable laws, regulations and Sobi policies
• Demonstrate 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