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    Senior Regulatory Affairs Specialist - Cambridge, United States - Validation Associates

    Validation Associates
    Validation Associates Cambridge, United States

    4 weeks ago

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    Description

    Contract Role:

    Schedule:

    It will be on average 20 hours per week, preferably 4 hours a day M-F, but we can be flexible depending on the candidate.


    • REMOTE
    • Regulatory Affairs Specialist DS Process Expert with NDA filing experience.
    May – September (20 hours week)


    Contractor to support regulatory documentation review for the Drug Substance part of the NDA submission and incorporation of QbD elements in respective section of Module 3.

    An experienced API contractor to help with the review process for our NDA submission.

    The external consultant should have extensive knowledge in synthetic peptide-based drugs, scale up experience, Regulatory CMC experience, and related areas to provide input in reviews/updates of the NDA Module 3 Quality sections 3.2.S.

    The external consultant should also have a good NDA submission track record.

    Pay Rate- Open

    This is a remote position.

    #J-18808-Ljbffr
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