· Lead end-to-end Clinical Trial Application project management across multiple studies and countries, ensuring alignment with timelines and regulatory requirements
· Plan, track, and deliver submissions across EU CTR and Rest of the World regions with meticulous attention to compliance and quality standards
· Manage risks, dependencies, and complexities in global regulatory environments through proactive identification and mitigation strategies
· Apply deep knowledge of EU CTR and ROW CTA requirements to ensure submissions meet all regulatory expectations
· Manage core clinical and regulatory documentation, maintaining accuracy and completeness throughout the submission lifecycle
· Collaborate with cross-functional global teams including clinical, regulatory, and operations to coordinate seamless submission execution
· Build and maintain strong stakeholder relationships across internal and external partners, resolving conflicts and ensuring alignment
· Monitor key performance indicators related to submission timelines and deliverable quality, driving continuous improvement
· Identify emerging risks and lead quality investigations as needed to maintain submission integrity