Chef principal, Affaires réglementaires
AbbVie · Montreal, Canada
RegulatoryFull timeCompany career page
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Role summary
Senior regulatory affairs leader responsible for directing a team of regulatory professionals and overseeing regulatory submissions to Health Canada for AbbVie's pharmaceutical and medical device products. The role combines scientific expertise with regulatory knowledge to support product development and commercialization while maintaining compliance with Canadian regulations.
What they're looking for
- Extensive experience in pharmaceutical regulatory affairs and Health Canada submissions
- Proven leadership and team management experience with direct reports
- Strong knowledge of Canadian food and drug legislation and regulatory guidelines
- Scientific background combined with regulatory and business acumen
- Experience with clinical trial applications, new drug submissions, and device regulations
- Excellent communication and stakeholder management skills
What you'll be doing
- Lead and supervise regulatory affairs team members and oversee their project activities
- Prepare and support strategic regulatory submissions including clinical trial applications and drug approvals
- Conduct mid-year and annual performance evaluations with direct reports and provide constructive feedback
- Review regulatory submission documents for compliance with Health Canada requirements and Food and Drugs Act
- Participate in pre-submission meetings with Health Canada and coordinate with global regulatory teams
Privacy & handoff
This role links to AbbVie's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.