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

📋 Description

• Develop and implement US/Canada regulatory strategic plans (RSTP) for products in development or on
• Ensure regulatory strategies align with GRPT and regulatory requirements.
• Gather data to support filings, inquiries, and registration maintenance for commercialization.
• Coordinate FDA meetings and briefing packages, interfacing with Health Authorities.
• Advise internal teams on Regulatory/FDA issues across functions (Public Affairs, Clinical
• Lead cross-functional regulatory submissions and respond to Health Authorities in a timely manner.

🎯 Requirements

• Advanced degree (PharmD/PhD/MS) or regulatory certification; min 5 years in Regulatory/R&D or
• Strong negotiation, problem solving, and consensus-building skills.
• Excellent written and verbal communication; able to convey challenging messages without harming
• Proven ability to implement affiliate regulatory strategies (US or Canada preferred).
• Experience in complex, matrix environments; experience interfacing with government regulators.
• Global regulatory experience is a plus.

🎁 Benefits

• Comprehensive benefits package including medical/dental/vision, PTO, and 401(k).
• Eligibility for long-term incentive programs.
• AbbVie Equal Opportunity Employer; inclusive and diverse culture.