Senior Regulatory Affairs Associate- Clinical Trial Application

About the role

We are seeking a Clinical Trial Submission Lead to join our team in a remote capacity. As a Clinical Trial Submission Lead, you will drive end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World regions. This position plays a critical role in ensuring timely, high-quality, and compliant submissions that advance new treatments for patients.

What you'll do

• 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

What you need

• 5–9 yrs of experience
• Regulatory affairs
• CRO
• Clinical research
• Documentation
• Communication
• B.Sc