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

📋 Description

• Develop and implement US and Canada regulatory strategic/tactical planning (RSTP) for assigned
• Collaborate with Global Regulatory Product Team to align strategies with regulatory and business
• Gather data to support filings, inquiries, and registration maintenance for commercialization.
• Lead lifecycle activities including change assessments, post-approval requirements, and FDA
• Coordinate/regulate submissions per US/Canada requirements and respond to Health Authorities.
• Present regulatory information to cross-functional teams and ensure policy compliance.

🎯 Requirements

• Advanced degree (PharmD, PhD, MS) or Regulatory certification.
• 5+ years Regulatory/R&D or related experience; medical device and digital health/software
• Experience with US/Canada regulatory strategies; FDA liaison experience a plus.
• Ability to operate in a complex, matrix environment and communicate effectively.
• Strong negotiation, problem-solving, and consensus-building skills.

🎁 Benefits

• Comprehensive benefits package and eligible for long-term incentive programs.
• Paid time off, medical/dental/vision coverage, 401(k) plans.
• AbbVie equal opportunity employer; commitment to integrity and inclusion.