Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
AbbVie124500 - 236500
Also available on
Job Description
📋 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.