Senior Manager 1, Submission Management
Core
Lead end-to-end regulatory submission strategies and production for US IND and marketing dossiers for global health authorities.
Role type
Senior Manager, Regulatory Submissions
Builds
eCTD submission dossiers and regulatory applications for global markets
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory practices, IND and marketing submission guidelines, stakeholder collaboration, cross-functional issue resolution, project management, strategic thinking, desktop software proficiency
Preferred skills
Science or technology degree background, experience in diverse therapeutic areas
Technologies
eCTD, desktop software
Responsibilities
Define submission strategies and document requirements, assess deliverables for compliance, drive execution of Global Submission Plans, manage lifecycle of applications and queries, lead a team of direct reports, drive continuous improvement initiatives
Seniority
Senior Manager, people management