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

📋 Description

• Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for on-market
• Ensure regulatory strategies align with GRPT and adapt 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 stakeholders on Regulatory/FDA issues and cross-functional communication.
• Prepare and review regulatory submissions to meet US and Canada requirements; support the

🎯 Requirements

• Advanced degree (PharmD, PhD, MS) or Regulatory certification with minimum 5 years regulatory
• Excellent negotiation, problem-solving, and consensus-building skills.
• Strong written and oral communication; ability to deliver challenging messages without harming
• Demonstrated success implementing affiliate regulatory strategies (US or Canada experience
• Experience in a complex, matrix environment; experience interfacing with government regulators

🎁 Benefits

• AbbVie offers a comprehensive benefits package, including PTO, medical/dental/vision insurance, and
• Eligible to participate in long-term incentive programs.
• AbbVie is an equal opportunity employer; commitment to integrity and innovation.