Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
AbbVie · North Chicago, IL
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Role summary
Senior Manager leading US and Canada regulatory strategy development and implementation for AbbVie's marketed and development-stage products. Serves as FDA liaison, prepares regulatory submissions, and advises cross-functional teams on compliance requirements.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on SmartRecruiters, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field
- Minimum 6 years regulatory affairs, R&D, or pharmaceutical industry experience
- At least 2–3 years performing pharmaceutical regulatory activities
- Strong negotiation, problem-solving, and consensus-building skills
- Excellent written and oral communication across regulatory and organizational functions
- Proven experience implementing US and Canada regulatory strategies
- Experience in complex, matrix organizational environments
What you'll be doing
- Develop and execute regulatory strategies for assigned product(s) across therapeutic areas
- Serve as liaison with FDA, coordinate briefing packages, and manage regulatory submissions
- Prepare and review regulatory submissions meeting US and Canada requirements
- Advise internal stakeholders including Clinical, Legal, and Commercial on regulatory matters
- Recommend and implement regulatory changes based on government guidance and corporate policy
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.