Senior Regulatory Affairs Specialist and Ireland

Senior Regulatory Affairs Specialist – (12‑Month Contract) / London (Hybrid)

Our client, a leading pharmaceutical organisation specialising in Dermatology
, is seeking an experienced Senior Regulatory Affairs Specialist to support UK & Ireland regulatory activities across medicinal products, medical devices and cosmetics. This role provides strategic and hands‑on regulatory leadership, ensuring compliance and enabling product launches and lifecycle management.

• Lead UK & Ireland regulatory strategy across POM (including biologics), P and GSL medicines.
• Manage submissions including MAH transfers, variations, renewals, PSURs/PBRERs
  .
• Partner with Global Regulatory Affairs to deliver accelerated approval strategies
  .
• Support product launches and ongoing product availability.
• Review and approve promotional and non‑promotional materials for regulatory compliance.
• Build strong relationships with MHRA and HPRA
  .
• Monitor regulatory and industry developments and assess business impact.
• Support GxP inspections and ensure all products meet regulatory requirements.
• Maintain regulatory files, documentation and databases.
• Provide guidance, training and ad‑hoc regulatory support to internal teams.

• Degree in Life Sciences
  .
• Minimum 5 years’ UK & Ireland regulatory experience (pre‑ & post‑approval).
• Strong experience interacting with MHRA and HPRA
  .
• Deep understanding of post‑Brexit/Windsor Framework regulatory pathways, including the International Recognition Procedure
  .
• Excellent attention to detail, documentation quality and cross‑functional collaboration.
• Strong communication, project management and stakeholder engagement skills.
• Fluent in English (written and spoken).
• Consumer and patient‑focused.
• Collaborative and open communicator.
• Innovative and proactive.

Monday to Friday, 37.5 hours per week

12 month Temporary contract

3 days per week, hybrid based in Euston, London