Job Description
When our values align, there's no limit to what we can achieve.
Job Summary:
The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.
Key Responsibilities:
Lead end-to-end CTA project management across multiple studies and countries
Plan, track, and deliver submissions aligned with timelines and regulatory requirements
Manage risks, dependencies, and complexities in global regulatory environments
Apply knowledge of EU CTR and ROW CTA requirements
Manage core clinical and regulatory documentation
Collaborate with cross-functional global teams