Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
AbbVie · Irvine, CA
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Role summary
Senior Manager Regulatory Affairs role responsible for developing and implementing US and Canada regulatory strategy for assigned pharmaceutical products, managing FDA interactions, and ensuring compliance with regulatory requirements throughout the product lifecycle.
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 Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.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 pharmaceutical regulatory affairs or R&D experience
- At least 2-3 years performing pharmaceutical regulatory activities
- Excellent negotiation, problem-solving, and consensus-building skills
- Strong written and oral communication across functional teams
- Proven experience implementing US and Canada regulatory strategies
- Experience working in complex matrix organizational environments
What you'll be doing
- Develop and execute regulatory strategic and tactical planning for assigned products
- Serve as FDA liaison coordinating meetings, briefing packages, and responses
- Prepare and review regulatory submissions meeting US and Canada requirements
- Provide regulatory guidance to cross-functional teams including clinical and commercial groups
- Recommend and implement regulatory changes based on government regulations and corporate policies
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.