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    Senior Manager, Regulatory Operations - Menlo Park, United States - Meet

    Meet
    Meet Menlo Park, United States

    3 weeks ago

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    Description

    Senior Manager, Regulatory Operations

    This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects.

    Responsibilities include:

    • Maintaining regulatory records within the Veeva Vault RIM system
    • Managing the change control process in Veeva Vault RIM
    • Ensuring up-to-date US/ex-US submissions and correspondence files within the Regulatory shared drive
    • Collaborating with external publishing vendors for e-submission files and receipts
    • Managing the spreadsheet tracking weekly/monthly regulatory submissions and communicating with external publishing vendors
    • Maintaining templates and style guides for regulatory submissions
    • Providing support to other Regulatory team members and their projects
    • Participating in the development of standard operating procedures

    Preferred Skills, Qualifications, and Technical Proficiencies:

    • Preferably experienced with Veeva Vault systems
    • Detail-oriented with excellent oral and written communication skills
    • Strong team player, self-motivated, capable of working independently and collaboratively
    • Ability to manage multiple projects simultaneously in a dynamic environment
    • Proficient in organization, prioritization, and time management
    • Proficiency in Microsoft Word, PowerPoint, and Excel

    Preferred Education and Experience:

    • BA/BS degree in a scientific discipline
    • 5+ years' experience in the pharmaceutical industry or life sciences, with at least 4 years in regulatory affairs

    Interested? Apply here and send your CV to

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