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    Senior Manager Regulatory Affairs - Dartford, United Kingdom - Qube Recruitment

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    Full time
    Description

    Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit a Senior Manager Regulatory Affairs & Pharmacovigilance.

    Job Requirements:

    Define, develop, and leads regional strategies to maximise regulatory and pharmacovigilance success. Effectively communicate the likelihood of pros and cons to Management.

    • Sound knowledge on requirements of MA Transfer in EU territories, which includes requirements of notarisations and translations.
    • Oversight a team of 4 to ensure day to day activities are carried out in Regulatory and Pharmacovigilance.
    • Sound Knowledge of requirements of Minor and Major complex Variations.
    • Ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies.
    • Responsible for reviewing and signing off bio-waiver declarations and quality overall summaries.
    • Support and carry out the Risk Assessments process as required by the business.
    • Provide oversight for the development and maintenance systems to ensure and support Regulatory and Pharmacovigilance compliance requirements are met.
    • Always assure inspection preparedness to support overall corporate strategy.
    • Ensure that procedures are in place and followed for effective working of the regulatory and pharmacovigilance department.
    • Provide organisation with strategic advice for the launch of new products in EU & UK.
    • Responsible for reviewing and signing off the agreements with external contactors.

    Representing the company with regulatory agencies across UK & EU

    • Monitoring and setting timelines for the team of individuals to meet the deadlines.
    • Monitoring and setting timelines for licence variations and renewal approvals.

    Qualifications and Experience (as applicable):

    • Educated to degree level in science or equivalent experience.
    • Minimum 10 years plus of experience in the Regulatory Affairs of Medicines, Food supplements and Cosmetics
    • Proficiency in the use of MS Office suite (Excel, PowerPoint)
    • Ability to take initiative and work with different departments as a team player within the organisation.
    Monday to Friday: Full Time


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