RIO Execution Hub (EH) Associate / Sr. Associate
Core
Provides operational regulatory support for designated countries, clusters, and regions, managing submission logistics and technical aspects of regulatory dossiers to ensure compliance and timely delivery.
Role type
Regulatory Operations Associate / Senior Associate
Builds
Regulatory dossiers (Module 1 components) and submission-ready documents for Health Authorities
Domain
Life Sciences / Pharmaceuticals
Required skills
Regulatory operations expertise, Project management, Dossier compilation, Translation management, Risk assessment, Quality review, Stakeholder collaboration, Process improvement, Digital tools adoption, Microsoft Office Suite
Preferred skills
Pharmaceutical organizational knowledge, Country/cluster regulatory trends, Regulatory/quality/compliance experience, Portuguese (LatAm EH)
Technologies
Microsoft Office Suite, Regulatory submission systems
Responsibilities
Plan regulatory submission timelines and ensure systems are up to date; Author, review, and maintain local regulatory documents (Module 1); Coordinate component receipt, translation, and dossier compilation; Escalate submission delays and develop mitigation strategies; Support tenders, out-of-stock reporting, and Annual Product Quality Reviews; Identify opportunities to streamline regulatory processes using digital tools.
Seniority
Associate (2+ years experience) / Senior Associate (3+ years experience), hands-on IC