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

Role: Lead regulatory strategy development and management for AbbVie's US and Canada markets, focusing on on-market products and development-stage assets. Responsibilities: oversee total product lifecycle activities including change assessments, regulatory submissions, health authority interactions (notably FDA), and post-approval compliance; collaborate cross-functionally with Clinical, Legal, Public Affairs, and Commercial teams; provide strategic guidance and mentorship to junior staff. Requirements: advanced degree (PharmD, PhD, MS) or regulatory certification; 7+ years in Regulatory affairs, R&D, or industry; extensive experience with US and Canada regulations, government agency engagement, and complex matrix environments. High-value: strong emphasis on US/Canada regulatory expertise, including experience with device or combination products (Class III preferred), manufacturing change control, and strategic regulatory planning. Work setup: location details not specified but implies senior, strategic role with significant cross-functional interaction, primarily within North America.