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