Senior Manager 1, Submission Management
Core
Lead end-to-end regulatory submission strategies and execution for US IND and marketing dossiers for global health authorities.
Role type
Senior Manager, Regulatory Submission Management
Builds
Compliant eCTD submission dossiers and global submission plans for pharmaceutical products
Domain
Life Sciences / Regulatory Affairs
Required skills
Global regulatory practices, eCTD dossier preparation, submission lifecycle management, team leadership, project management, stakeholder collaboration
Preferred skills
Science/technology degree background, experience in continuous improvement initiatives
Technologies
eCTD, desktop software
Responsibilities
Define IND and marketing submission strategies and document requirements, assess core submission deliverables for compliance, drive execution of the Global Submission Plan, manage submission production activities and lifecycle management, lead a team of direct reports managing resource allocation, drive initiatives to simplify processes and enhance efficiencies
Seniority
Senior Manager, people management