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    Associate Director Regulatory Affairs CMC - United Kingdom - wax.

    wax.
    wax. United Kingdom

    3 weeks ago

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    Description


    Our client, a successful and growing Biotechnology organisation, is looking to hire a new addition to the Regulatory CMC team.

    This role is responsible for preparing regulatory CMC submission strategy for rare disease drugs (both biologics and small molecules) and an opportunity to design creative solutions in order to obtain approval for initial BLA/NDA as well as post-approvals variation in ROW markets.


    Key responsibilities:

    • Prepares various regulatory CMC documents in a timely and appropriate manner according to the product development plan Manages regulatory schedules for product development plan and submissionsWorking with internal concerned departments, prepares appendices attached to regulatory CMC documents to be submitted to regulatory authority and submits themDevelops and manages innovative regulatory CMC strategies and risk assessments for biologics and small moleculesContribute to the Global Regulatory CMC Strategy Responsible for direct contact/liaison with various health authorities on specific CMC topics.
    Manages and directly contributes to HA meeting briefing documents in collaboration with global regulatoryAssures that appropriate contacts with Health AuthoritiesExplores opportunity for efficiency improvement in the dossier preparation process and takes actions to promote new ideasConducts regulatory impact assessment and provide appropriate regulatory strategy for these changes that requires regulatory actionsManages and directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with global CMC DossierSuitable applicants will have:

    • Knowledge of global regulations/guidelines, Key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues. quality consultations and other CMC focused regulatory meetings in collaboration with Global regulatory and other CMC functionsExperience in preparation and submission of post-marketed CMC change controls for biologics and small molecules
      **This company offers a great culture and a competitive package
      *
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