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    Senior Regulatory Affairs Manager CMC - Cambridge, Cambridgeshire, United Kingdom - Pharma Partners Recruitment Ltd

    Pharma Partners Recruitment Ltd
    Pharma Partners Recruitment Ltd Cambridge, Cambridgeshire, United Kingdom

    5 days ago

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    Description

    Job title:

    Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC.

    The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector) experience.


    Responsibilities:


    for the development and execution of global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applicationswith internal Technical Operations colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspectionsthe preparation, drafting, review, risk analysis and mitigation planning of CMC submissions e.g.


    Module 3 IND, IMPD, amendments and annual reportsRequirements:

    in CMC Regulatory Affairs within the pharmaceutical or biotechnology industryand knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is requiredknowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulationsworking with recombinant proteins is highly desirableinteractions with health authorities such as scientific advice or agency meetings, including with FDA, is desirableof first degree in life sciences (or equivalent); advanced degree (e.g.

    PhD or Masters) preferred.


    Salary and benefits:
    A highly competitive salary, stock options, annual bonus and wider benefits package is on offerTo apply for this position or hear further details then please contact Matt Thomas via
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