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UL LLC

Research Triangle Park (Remote), North Carolina

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San Francisco, California

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Senior Manager Regulatory Affairs
Responsibilities: Work with the department head to develop regulatory strategies for assigned projects across all phases of product development aimed at achieving marketing authorization and appropriate product labeling  Serve as regulatory representative on cross-functional teams and lead sub-teams to meet program objectives. Plan, review and prepare INDs, NDAs and all related annual reports, amendments, supplements, and continued maintenance of approved marketed products Primary point of contact for interfacing with Health Authority Regulatory Project Manager for assigned products Lead cross-functional teams in the planning and execution of responses to regulatory authorities Work with Regulatory Operations team to e


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