RIO Execution Hub (EH) Manager
Pfizer Incorporated
Senior manager overseeing regulatory submission operations and compliance for assigned countries and regions. Coordinates development and delivery of regulatory dossiers, manages submission timelines, and partners with cross-functional teams to enable timely market access while maintaining regulatory standards.
Responsibilities
- Lead and coordinate moderate to complex regulatory submissions aligned with business priorities
- Author, review, and maintain local regulatory documents and dossier components for assigned markets
- Manage dossier compilation, translation, legalization, and submission readiness activities
- Track operational performance against KPIs, quality metrics, and audit requirements
- Escalate submission delays and develop mitigation strategies addressing identified risks
Requirements
- Regulatory operations expertise and submission management experience
- Strong project management and timeline planning capabilities
- Proficiency with digital tools and regulatory systems
- Experience authoring and reviewing Module 1 dossier components
- Ability to collaborate across diverse functions and geographic regions
- Knowledge of health authority submission requirements and compliance processes
Vacancy posted 2 days ago
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