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    Senior Regulatory Affairs Manager/ Consultant - England, United Kingdom - Clinical Professionals Limited

    Clinical Professionals Limited
    Clinical Professionals Limited England, United Kingdom

    Found in: Jooble UK O C2 - 1 day ago

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    Description
    Senior Regulatory Affairs Manager/ Consultant

    Job Type:
    Contract

    Senior Regulatory Affairs Manager/ Consultant – 12 Months Contract
    Berkshire, UK – Hybrid
    £60-70PH PAYE

    We are partnered with a leading Pharmaceutical organisation who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis.

    This product will support a combination product portfolio and will be driving European Regulatory Strategies and must be experienced in interacting with EU health authorities.

    Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds typically marketed for the European area.


    • Identify and advocate region's requirements in the overarching global regulatory strategy; and make sure it is taken into account at the Global Regulatory Project Team (GRPT).
    • Primary Regulatory Affairs (RA) interface with Commercial and in collaboration with the Regulatory Affairs personnel in the affiliates.
    • Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
    5 years of Regulatory experience with a strong background in EU submissions.

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