Senior Regulatory Affairs Associate- Clinical Trial Application

About the role

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

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
• Manage core clinical and regulatory documentation, maintaining accuracy and completeness throughout the submission lifecycle

What you need

• Regulatory affairs
• Documentation