Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
AbbVie
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 5 days ago
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