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

📋 Description

• The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible
• Ensure regulatory strategies defined within the GRPT are implemented and maintained in line with
• Gather data to support filings, responses to inquiries, and registration maintenance to enable
• Interface with FDA meetings, teleconferences, and prepare FDA briefing packages and responses.
• Advise internal teams on Regulatory/FDA issues including Public Affairs, Clinical Development
• Contribute to preparation and review of regulatory submissions and maintain alignment with US and

Qualifications

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
• 6 years Regulatory, R&D, or Industry-related experience
• Experience in a complex/matrix environment; interfacing with government regulatory agencies
• 2-3 years in pharmaceutical regulatory activities; global regulatory experience a plus
• Excellent negotiation and communication skills; ability to deliver challenging messages while
• Proven skill at implementing US and Canada regulatory strategies

🎁 Benefits

• AbbVie offers a comprehensive benefits package including paid time off, medical/dental/vision
• Long-term incentive programs
• Equal Employment Opportunity; includes Veterans/Disabled