Chef principal, Affaires réglementaires

AbbVie seeks a Senior Director of Regulatory Affairs to lead a team managing regulatory submissions and approvals with Health Canada for pharmaceutical and medical device products. The role involves strategic oversight of filing activities, stakeholder collaboration, and ensuring compliance with Canadian regulatory requirements across development and commercialized products.

Responsibilities

• Lead and supervise regulatory affairs team, manage projects, and ensure submission deadlines are met
• Prepare and support strategic regulatory submissions including clinical trial applications and new drug presentations
• Conduct performance evaluations and provide ongoing constructive feedback to direct reports
• Review regulatory documents for compliance with Health Canada requirements and Food and Drug Act
• Support pre-submission meetings with Health Canada and coordinate with global regulatory teams

Requirements

• Extensive experience in regulatory affairs and Health Canada submissions
• Demonstrated leadership and team management experience
• Deep knowledge of Canadian pharmaceutical and medical device regulations
• Strong understanding of clinical trial, new drug, and post-approval submission processes
• Excellent written and verbal communication skills in French and English
• Scientific background combined with regulatory and business acumen