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    Senior Associate - London, United Kingdom - Clinical Professionals Limited

    Clinical Professionals Limited
    Clinical Professionals Limited London, United Kingdom

    Found in: Jooble UK O C2 - 2 days ago

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    Description
    Associate Director, Regulatory Affairs CMC

    Job Type:
    Permanent

    Associate Director, Regulatory Affairs CMC/ Senior Manager
    An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy. As a Regulatory Affairs, CMC lead for developing programs.

    This is an exciting opportunity to demonstrate your knowledge in managing regulatory processes from authoring CMC sections for developing biological/Small Molecule products including working as an SME for RA CMC processes.

    A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology.

    Support regulatory CMC writing activities including authoring CMC sections in development including, CTA, IND, BLA, NDA, IMPD, and MAA.
    Supporting global CMC regulatory strategy including working cross-functional with key stakeholders inside and outside the organisation.
    Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations.

    Minimum of a Bachelor's degree in a Scientific or Technical Discipline; A highly specialized individual contributor with advanced CMC regulatory knowledge and expertise in a professional discipline.

    ~6-10 years of CORE regulatory CMC experience ideally in both small and large molecules.
    ~ Must have previous experience authoring Regulatory Clinical CMC sections for EU/US submissions.
    ~ Change Control assessment experience (application of relevant regulatory guidance to proposed change).

    This is an excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development.

    You will be supported by an established CMC team providing excellent career progression opportunities and a chance to work as a senior figure in the RA CMC team.

    The role comes with some excellent benefits including a bonus, car allowance life assurance, pension scheme, and private healthcare.
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