Pharmacy Regulatory Affairs Manager

2 weeks ago


Dublin, Dublin City, Ireland The Boots Company PLC Full time

This position plays a significant role in ensuring the safety and authorization of healthcare products for the Irish market, while also maintaining compliance with legal and regulatory standards:

  • Verify the safety and authorization of healthcare products sold in Ireland
  • Ensure that healthcare promotions and advertising adhere to legal guidelines
  • Establish strong connections with commercial teams and external organizations
  • Collaborate with internal and external stakeholders to source, license, and market medicines correctly for Ireland
  • Prepare documentation for audits and ensure promotional materials comply with legal requirements
  • Manage the Assistant Regulatory Affairs Manager and contribute to One Healthcare Strategy
  • Work closely with various teams to ensure compliance with regulations for merchandising and digital content
  • Provide expertise on licensing and healthcare regulations
  • Maintain accurate data on licensed medicines in Ireland
  • Build relationships with Regulatory Agencies to ensure compliance with legislation
  • Respond to regulatory consultations regarding healthcare products
  • Focus on patient safety and take necessary actions to ensure it
  • Implement changes confidently and assist others in embracing change

Key Skills:

  • Demonstrate enthusiasm and passion for pharmacy
  • Strong interpersonal skills and the ability to represent Boots Ireland effectively
  • Understanding of regulatory bodies such as HPRA, DaFF, PSI
  • Familiarity with Irish and UK medicines and pharmacy regulations
  • Knowledge of European regulations for medical devices, supplements, biocides, and cosmetics
  • Effective verbal and written communication skills
  • Proficient in IT

Experience:

  • Extensive background in retail pharmacy
  • Ability to influence at a senior level

Qualifications:

  • Pharmacist with a degree in Pharmacy (B. Sc Pharm, B Pharm, or M Pharm) and a minimum of 3 years of experience
  • Registered with the Pharmaceutical Society of Ireland (MPSI)

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