Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid

📋 Description

• Lead US & Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or
• Ensure regulatory strategies align with GRPT and respond to changing regulatory and business needs.
• Gather data to support filings, responses to inquiries, and registration maintenance for
• Serve as Health Authority liaison, interfacing with FDA for meetings and briefing packages.
• Advise internal teams on Regulatory/FDA issues across Regulatory, Clinical, Legal, Public Affairs
• Prepare and review US/Canada regulatory submissions and ensure timely responses to Health

🎯 Requirements

• Advanced degree (PharmD, PhD, MS) or Regulatory certification with minimum 5 years
• Strong negotiation, problem-solving, and consensus-building skills.
• Excellent written and oral communication within Regulatory and across the organization.
• Proven experience implementing affiliate regulatory strategies (US/Canada preferred).
• Experience in complex, matrix environments and interfacing with government regulators.
• Global regulatory experience is a plus.

🎁 Benefits

• AbbVie offers comprehensive benefits including PTO, medical/dental/vision, and 401(k).
• Eligibility for long-term incentive programs.