Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
AbbVie · Florham Park, NJ
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Role summary
Senior Manager Regulatory Affairs position focused on developing and executing US and Canada regulatory strategies for marketed and developmental products. Responsibilities include FDA liaison activities, regulatory submission preparation, and cross-functional coordination to ensure compliance with regulatory 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 Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.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
- Proven experience implementing US and Canada regulatory strategies
- Strong negotiation, problem-solving, and consensus-building skills
- Experience interfacing with government regulatory agencies
- Ability to work effectively in complex matrix environments
What you'll be doing
- Develop and implement regulatory strategic and tactical planning for assigned products in US and Canada
- Serve as health authority liaison and coordinate FDA meetings, briefing packages, and responses
- Prepare and review regulatory submissions ensuring compliance with US and Canada requirements
- Advise internal stakeholders on regulatory and FDA matters across clinical, legal, and commercial functions
- Recommend and implement regulatory changes based on government guidance 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.