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

Added
1 day ago
Type
Full time
Salary
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Related skills

regulatory submissions fda regulatory compliance health authority qdp

📋 Description

  • Develop and implement US & Canada regulatory strategy for Therapeutic Neurotoxins.
  • Gathers data to support filings and registrations for commercialization.
  • Act as Health Authority liaison with FDA; prepare briefing packages and responses.
  • Advise internal teams on Regulatory/FDA issues across functions.
  • Independent negotiation and decision-making on cross-functional projects.

🎯 Requirements

  • Advanced degree (PharmD/PhD/MS) or regulatory certification; 5+ years regulatory/R&D or
  • Preferred advanced degree/certifications or direct regulatory experience.
  • Excellent negotiation, problem solving, and consensus-building skills.
  • Strong written and oral communication within Regulatory and across org.
  • Experience implementing affiliate regulatory strategies (US/Canada preferred).
  • Experience in complex, matrix environments; interface with government regulators.

🎁 Benefits

  • Comprehensive benefits package including PTO, medical/dental/vision, and 401(k).
  • Eligible for long-term incentive programs.
  • AbbVie is an equal opportunity employer.
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