Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)

📋 Description

• Develop and implement US and Canada regulatory strategies for assigned products.
• Coordinate regulatory strategy with cross-functional teams to meet business needs.
• Serve as HA liaison and interface with FDA for meetings and briefing packages.
• Support regulatory submissions and respond to Health Authorities timely.
• Contribute to regulatory strategy development and training of staff.
• Represent regulatory in cross-functional initiatives affecting product strategy.

🎯 Requirements

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
• 6 years Regulatory, R&D, or Industry experience
• Experience interfacing with government regulatory agencies
• Excellent negotiation and communication skills
• Ability to deliver messages without compromising business relationships
• Proven ability to implement US and Canada regulatory strategies

🎁 Benefits

• AbbVie is an equal opportunity employer
• Comprehensive benefits including PTO and health insurance
• Eligible for long-term incentive programs