Regulatory affairs manager - (CTIS/Veeva/AI)
Core
Lead operational execution of Clinical Trial Authorizations (CTA) submissions for designated Clinical Trial Agreements (CTAs) within a sponsor-dedicated model.
Role type
Senior Regulatory Submission Manager
Builds
Global regulatory submission packages for clinical trials
Domain
Clinical Trials / Regulatory Affairs / Life Sciences
Required skills
CTIS system expertise, Veeva submissions experience, CTA process execution, Central Ethics processes, global submission strategy, stakeholder management, translation coordination, RFI processing, financial transaction management
Preferred skills
Degree in Pharmacy, Life Sciences, Business, or IT
Technologies
CTIS, Veeva
Responsibilities
Drive global submission management strategy and activities for assigned protocols; Lead and attend relevant meetings to advocate realistic deliverable timelines; Support and lead global team efforts to ensure high quality components and submissions; Liaise with Sponsor Core team, SSU and Study Management regarding essential core documents; Prepare, review and support Sponsor submissions to HA/Regional CTA Hub; Coordinate translations for core documents required for submission; Manage the compilation for core package build; Process incoming requests for information (RFIs) and payments; Act as local country liaison when required; Escalate and resolve issues impacting submission builds or logistics; Discuss interpretation of dossier requirements with Sponsor SMEs.
Seniority
Senior, hands-on IC