Senior Manager, Regulatory Affairs Process Excellence
AbbVie
Senior Manager overseeing regulatory affairs process excellence and issue management at a pharmaceutical company. Responsible for managing compliance systems, triaging issues, driving process improvements, and supporting audit readiness across cross-functional teams.
Responsibilities
- Manage Regulatory Affairs Issue and CAPA Management system (RAIM) for logging, assessment, tracking, and resolution
- Triage issue records to determine severity and impact, escalating to Exception Reports when appropriate
- Project manage Exception Reports with cross-functional teams to identify root causes and drive corrective actions
- Support audit and inspection readiness through documentation coordination and response assistance
- Oversee legacy company integration into Regulatory Affairs processes through change management
Requirements
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology, or related field)
- 8+ years regulatory, pharmaceutical, or device industry experience
- Experience managing issue/CAPA systems and exception reporting workflows
- Experience supporting audit and inspection readiness in regulated environments
- Strong organizational, analytical, communication, and stakeholder management abilities
- Ability to manage multiple priorities and influence across functions without direct authority
Vacancy posted 7 days ago
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