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

📋 Description

• Develop and implement US & Canada regulatory strategy (RSTP) for assigned products.
• Ensure regulatory strategies align with GRPT and evolving regulatory needs.
• Gather data to support filings, responses, and registration maintenance.
• Interface with FDA for meetings and briefing packages.
• Advise internal teams on Regulatory/FDA issues and cross-functional impacts.
• Prepare and review regulatory submissions for US/Canada and respond to Health Authorities.

🎯 Requirements

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related).
• 6 years Regulatory, R&D, or industry experience.
• Experience in complex, matrix environments and government interfaces.
• Strong negotiation and communication skills.
• Proven ability to implement US/Canada regulatory strategies.

🎁 Benefits

• AbbVie benefits package including PTO and health coverage.
• Eligibility for long-term incentive programs.