Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device

Role: Lead regulatory strategic and tactical planning for AbbVie's US and Canada markets, focusing on on-market products and development pipeline, primarily within immunology, oncology, and neuroscience. Responsibilities: develop and execute regulatory strategies, oversee product lifecycle activities (e.g., change assessments, post-approval compliance, Health Authority interactions), and coordinate regulatory submissions in line with regional requirements. Acts as a key liaison with FDA, advises internal cross-functional teams, and mentors junior staff. Qualifications: advanced degree (PharmD, PhD, MS) or regulatory certification; minimum 7 years of relevant experience in regulatory affairs or R&D; extensive experience with US/Canada regulations, Health Authorities, and complex or matrixed environments. HighValue: US/Canada market focus, regulatory strategy leadership, lifecycle management, FDA interface, experience with complex medical devices (Class III) and combination products, involvement in regulated communications, and potential experience in global regulatory settings. WorkSetup: not specified in the description.