Regulatory Operations Manager

VirtualVocations
Olympia Heights, Florida, United States
Full-time

A company is looking for a Regulatory Operations Manager (eCTD Submissions Management).Key ResponsibilitiesManage eCTD submission processes for global development and lifecycle managementCoordinate publishing deliverables and oversee outsourced publishing activitiesEnsure compliance with regulatory agency guidelines and quality standards for submissionsRequired Qualifications3-5 years of experience in regulatory operations for US and EuropeExperience overseeing publishing vendors is preferredExpert knowledge of submission-related health authority guidelines and regulationsCompetence in using electronic document management and submissions publishing toolsAbility to drive timelines and manage deliverables from the authoring community

4 days ago
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