RIO Execution Hub (EH) Manager
Core
Lead operational regulatory support and submission logistics for designated countries, clusters, and regions, ensuring the development and delivery of regulatory dossiers from initial application through lifecycle updates.
Role type
Senior Manager, Regulatory Operations
Builds
Regulatory dossiers (Module 1 components) and submission-ready documents for Health Authorities
Domain
Life Sciences / Regulatory Affairs
Required skills
Project management, Regulatory operations expertise, Digital tools proficiency, Cross-functional collaboration, Risk assessment, Quality review, Stakeholder engagement, Process improvement, Resource planning, Change management
Preferred skills
Experience with complex lifecycle applications, Matrix oversight of global publishing teams, Digital automation solutions, Continuous improvement methodologies
Technologies
Regulatory submission systems, Document management tools, Digital automation platforms
Responsibilities
Lead and coordinate moderately to complex regulatory submissions; Author and review local regulatory documents (Module 1); Manage dossier compilation, translation, and submission readiness; Track operational performance against KPIs and audit requirements; Escalate submission delays and develop mitigation strategies; Partner with cross-functional stakeholders for tenders, audits, and launch planning; Drive adoption of standardized document processes and digital solutions.
Seniority
Senior Manager, hands-on leadership