Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device (Hybrid)

AbbVie seeks a Senior Manager of Regulatory Affairs to lead US and Canada regulatory strategy for aesthetics devices. The role involves developing and implementing regulatory plans for marketed and pipeline products, managing FDA interactions, and supporting cross-functional teams to ensure compliance with regulatory requirements.

Responsibilities

• Develop and execute US and Canada regulatory strategy and tactical planning for assigned products
• Lead product lifecycle activities including manufacturing changes, post-approval requirements, and health authority interactions
• Manage FDA interface for key projects and serve as primary liaison for meetings and submissions
• Coordinate preparation and review of regulatory submissions to ensure compliance and timely responses
• Advise internal stakeholders on regulatory and FDA matters across multiple functions

Requirements

• Advanced degree (PharmD, PhD, MS) or regulatory certification
• 5+ years regulatory, R&D, or equivalent industry experience
• Medical device industry experience required
• Digital health/software experience
• Proven success implementing affiliate regulatory strategies in US or Canada
• Experience interfacing with government regulatory agencies
• Strong negotiation, problem-solving, and communication skills