Manager, Submission Management
Core
Lead end-to-end regulatory activities for clinical trial submissions, ensuring compliance with global health authorities and driving process improvements.
Role type
Senior Manager, Regulatory Submissions (Clinical Trials)
Builds
Global CTA dossiers and compliant clinical trial submissions for health authorities
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Global regulatory practices, CTA dossier preparation, EU CTIS management, stakeholder negotiation, project management, team leadership, strategic thinking
Preferred skills
Science/technology degree background, experience in diverse therapeutic areas
Technologies
EU CTIS, desktop software
Responsibilities
Define clinical trial submission strategies and document requirements; prepare and distribute global CTA dossiers; monitor regulatory assessment processes and resolve information requests; manage queries and commitments with health authorities; lead a team managing resource allocation and project assignments; drive continuous improvement initiatives to enhance team efficiencies.
Seniority
Senior, hands-on IC with people management