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.
Role type
Senior Specialist, Regulatory Submission Management
Builds
Regulatory dossiers (IND and marketing applications) for global health authorities
Domain
Life Sciences / Regulatory Affairs
Required skills
End-to-end submission management, Global regulatory requirements knowledge, IND/eCTD expertise, Cross-functional stakeholder coordination, Risk and timeline management, eCTD publishing execution
Preferred skills
Veeva RIM proficiency, Lorenz docuBridge familiarity, Process improvement mindset, 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, identify risks, and 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