Senior Regulatory Affairs Associate- Clinical Trial Application
Core
End-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World regions to ensure timely, compliant submissions.
Role type
Senior Regulatory Affairs Associate (Clinical Trial Application)
Builds
Clinical Trial Applications (CTA) for EU CTR and ROW regions
Domain
Pharmaceutical / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Project management, Regulatory knowledge (EU CTR & Global Submissions), Risk and issue management, Clinical documentation management, Global matrix environment navigation
Preferred skills
Stakeholder engagement, Conflict resolution, KPI monitoring, Quality investigation leadership
Responsibilities
Lead end-to-end CTA project management across multiple studies and countries, Plan and track submissions aligned with timelines and regulatory requirements, Manage risks and dependencies in global regulatory environments, Manage core clinical and regulatory documentation, Monitor KPIs related to timelines and deliverable quality, Identify risks and lead quality investigations as needed
