Supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives
Job Summary
Supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives.
Collaborate with global and local stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
Lead a team of direct reports managing resource and allocation and assigned projects, provide training and mentoring to new staff, and support team with development and innovation.
Matching Summary
Supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives.
Skills & Requirements
Must-have
clinical trial submissions
regulatory strategy
health authority negotiations
continuous improvement initiatives
CTA dossier preparation
Nice-to-have
transforming patient lives
innovation and efficiency
collaboration and inclusion
work-life balance
Key Requirements
7+ years relevant regulatory submissions experience