Senior Manager Regulatory Affairs

VirtualVocations
Olympia Heights, Florida, United States
Full-time

A company is looking for a Sr. Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities.

Key ResponsibilitiesPrepare and oversee complex regulatory CMC submissions for investigational and commercial productsCollaborate with cross-functional teams to develop CMC submission plans aligned with business objectivesLead interactions with FDA and other Health Authorities regarding CMC-related topicsRequired QualificationsExperience in Regulatory Affairs CMC or relevant industry experience with an advanced degreeExperience with Life Cycle ManagementDemonstrated track record of managing CMC Regulatory activities in a global matrix team environmentDeep understanding of global regulatory requirements and guidelines

11 days ago
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