Pharmacy Regulatory Affairs Manager

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: Pharmacist - B. Sc Pharm, B Pharm or M Pharm. 3 Years+ experience desirable Registered with Pharmaceutical Society of Ireland - MPSI
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