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    Associate Director Regulatory Affairs CMC - United Kingdom - wax.

    wax.
    wax. United Kingdom

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    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 submissions

    Working with internal concerned departments, prepares appendices attached to regulatory CMC documents to be submitted to regulatory authority and submits them

    Develops and manages innovative regulatory CMC strategies and risk assessments for biologics and small molecules

    Contribute 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 regulatory

    Assures that appropriate contacts with Health Authorities

    Explores opportunity for efficiency improvement in the dossier preparation process and takes actions to promote new ideas

    Conducts regulatory impact assessment and provide appropriate regulatory strategy for these changes that requires regulatory actions

    Manages and directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with global CMC Dossier

    Suitable 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 functions

    Experience 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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