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