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    Pharmacy Regulatory Affairs Manager - Dublin, Ireland - The Boots Company PLC

    The Boots Company PLC
    The Boots Company PLC Dublin, Ireland

    2 weeks ago

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    Description

    This role makes a big difference to our shops and our customers by:

    • Ensuring that the healthcare products we sell are safe and fully authorised for the Irish market
    • Ensuring that all healthcare promotions, advertising and merchandising are in line with legal and regulatory guidelines for Ireland
    • Building strong relationships and connections with our commercial teams and external bodies
    • Using those relationships to ensure we act in line with current legislation Key responsibilities:
    • Work with other internal and external stakeholders to ensure all medicines and healthcare products are sourced, licensed and marketed correctly for the Republic of Ireland
    • Preparation and production of documentation for internal and external audits
    • Ensures all healthcare and pharmacy promotional, advertising and internal training material is in line with legal and professional requirements.
    • Line management of Assistant Regulatory Affairs Manager
    • Contributing to and implementation of One Healthcare Strategy
    • Work with the Ireland Category teams to ensure merchandising plans are in line with regulations in Ireland
    • Work with Digital teams to ensure that healthcare related content online is compliant with regulations in Ireland
    • Maintain best practice documentation to ensure that BUK and BRIL are operating in line with their legal and regulatory obligations
    • Provide expertise and advice on all licensing and healthcare product regulations internally.
    • Own the master data for medicines licensed in Ireland and proactively keep this up to date.
    • Builds strong relationships with the Regulatory Agencies (e.g. HPRA, FSAI and PSI) to ensure that Boots is operating in line with current legislation.
    • Responding to Regulator public consultations relating to healthcare products or pharmacy practice issues
    • Takes patient care and safety very seriously and takes action to ensure our patients safety is paramount
    • Leads and implements agreed changes with confidence and courage, helping people 'get' the change and embrace it Skills:
    • Natural energy/enthusiasm and passion for pharmacy as a profession
    • Strong relationship building and interpersonal skills – a credible brand ambassador for Boots Ireland.
    • Understanding of key Regulators ways of working ( HPRA, DaFF, PSI)
    • Good understanding of Ireland and UK medicines and pharmacy regulations
    • Knowledge of Ireland and European regulations and guidelines for medical devices, food supplements, biocides and cosmetics
    • Good communication skills both verbal and written, with the ability to work with a wide range of business partners
    • Good IT skills Experience:
    • Deep understanding of retail pharmacy
    • Ability to influence at a senior level internally and externally Qualifications:
    • Registered with Pharmaceutical Society of Ireland – MPSI

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