Pharmacy Regulatory Affairs ManagerJob reference: 136285BR
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
- 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
- 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
- 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
- Pharmacist – B. Sc Pharm, B Pharm or M Pharm
- Registered with Pharmaceutical Society of Ireland – MPSI