Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada

Role: Senior Manager Regulatory Affairs, US & Canada, responsible for developing and executing regulatory strategic and tactical plans for on-market products and those in development within AbbVie's therapeutic areas, including immunology, oncology, and neuroscience. Responsibilities: serve as the primary interface with Health Authorities like FDA, prepare and review regulatory submissions, ensure compliance with US and Canada regulations, and support approval processes. The role involves cross-functional collaboration with Clinical Development, Legal, and Commercial teams, and entails negotiating with regulators, managing regulatory documentation, and maintaining registration activities. Requirements: Bachelor's degree in pharmacy, biology, chemistry, or related field; minimum 6 years of regulatory affairs or pharma industry experience, including 2-3 years of regulatory activities; strong negotiation and communication skills; demonstrated success in US and Canada regulatory strategies; familiarity with government agencies and complex matrix environments. Preferred: advanced degree, industry certifications, and global regulatory experience. High-Value: focus on regulated products in immunology, oncology, or neuroscience, supporting marketed assets and development-stage products. Work setup: hybrid schedule based in Lake County, IL; Florham Park, NJ; or Irvine, CA; with significant interaction with US and Canada health authorities.