Pharmacy Regulatory Affairs Manager

Job reference: 136285BR Previous
Location: Dublin, City West
Function area: Pharmacy
Shift pattern: Full-time
Contract type: Secondment
Hours per week: Over 35 hours per week
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.
  • 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 ROI 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 an infectious 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:

  • Previous experience in a regulatory affairs role in a consumer health area would be a strong advantage
  • 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
  • Registered with Pharmaceutical Society of Ireland – MPSI