Regulatory Affairs Senior Specialist - Submission Manager
Core
Lead global regulatory submission planning, coordination, and delivery across the product lifecycle from First-in-Human to license withdrawal.
Role type
Senior Regulatory Affairs Submission Manager
Builds
Global regulatory dossiers (eCTD) for clinical trial and marketing authorization
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Regulatory submission planning, eCTD structure, dossier compilation, cross-functional coordination, risk monitoring, stakeholder management, project management
Preferred skills
EU and/or US submission experience, Veeva regulatory systems, clinical trial or marketing authorization experience
Technologies
eCTD, Veeva
Responsibilities
Lead planning and delivery of global regulatory submissions; Develop and manage submission plans, timelines, and milestones; Coordinate dossier preparation and compilation; Partner with global, regional, and local Regulatory Affairs teams; Coordinate inputs across Regulatory CMC, Medical Writing, Clinical Development, and external partners; Monitor submission progress and resolve issues; Provide status updates to clients and stakeholders; Support lifecycle activities including dossier maintenance.
Seniority
Senior, hands-on IC