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Regulatory Start-Up Manager

Company: VirtualVocations
Location: Vista
Posted on: May 24, 2025

Job Description:

A company is looking for a Regulatory Start Up Manager II to join their Global SSU team.
Key Responsibilities

Develop and manage the Regulatory & start-up submission project plan, ensuring compliance with timelines and deliverables
Act as a liaison with the Sponsor for the approval and collection of core documents and submission packages
Review submission components and provide feedback on regulatory acceptability, including master IP labels

Required Qualifications

University degree in pharmacy, medicine, or related natural sciences is preferred
Minimum of 7 years of professional experience, including 4 years as a Regulatory Start-up Manager at a local/country level
At least 2 years of hands-on experience in global studies
Experience working with multiple countries in global studies
Working knowledge of FDA Guidance Documents, EU Directives, and ISO14155 regulations

Keywords: VirtualVocations, National City , Regulatory Start-Up Manager, Executive , Vista, California

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