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    Senior Regulatory Affairs Specialist - Cambridge, United States - VALIDATION ASSOCIATES LLC

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    Description

    Job Description

    Job 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.
    More relevant peptide API experience, and experience with implementing QbD for API and current QbD knowledge needed.
    Also, some experience with peptides to be used for injectables.

    Pay Rate- Open

    This is a remote position.


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