Senior Specialist, Submission Management
Core
Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time while driving consistency and operational excellence.
Role type
Senior Specialist, Regulatory Submission Management
Builds
IND and global marketing application submissions for innovative medicines
Domain
Life Sciences / Regulatory Affairs
Required skills
End-to-end submission management, Global regulatory requirements knowledge, eCTD publishing, Stakeholder coordination, Risk and timeline management, Veeva RIM proficiency, Lorenz docubridge familiarity
Preferred skills
Experience with non-eCTD submissions, Process improvement initiatives, Digital tools and automation adoption
Technologies
Veeva RIM, Lorenz docubridge
Responsibilities
Lead coordination of submission activities across global teams, Partner with stakeholders to define submission strategy and timelines, Manage IND and marketing application submissions from planning through to delivery, Track progress and identify risks to ensure milestones stay on track, Execute eCTD publishing and manage submissions via HA portals, Maintain submission data, reporting, and tracking in Veeva RIM
Seniority
Senior, hands-on IC