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

📋 Description

• Develop US & Canada regulatory strategy for assigned products
• Implement regulatory strategy per GRPT guidance
• Gather data for filings and responses to authorities
• Interface with FDA for meetings and briefing packages
• Advise internal teams on Regulatory/FDA issues
• Prepare and review regulatory submissions per US/Canada rules

🎯 Requirements

• Bachelor’s degree in a related field
• 6 years Regulatory, R&D, or industry experience
• Experience in complex matrix environments
• Experience interfacing with regulatory agencies
• Strong negotiation and communication skills
• Ability to deliver regulatory strategies for US/Canada

🎁 Benefits

• Comprehensive benefits package including PTO and health insurance
• Participation in long-term incentive programs
• AbbVie equal opportunity employer