Senior Regulatory Affairs Specialist UK and Ireland - #2128459

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.

Key Responsibilities

• 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.
• Maintain packaging artwork updates via Veeva PromoMats.
• 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.

Experience & Skills

• 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).

Behavioural Competencies

• Consumer and patient‑focused.
• Collaborative and open communicator.
• Innovative and proactive.
• Delivers high‑quality, right‑first‑time outcomes.

Monday to Friday, 37.5 hours per week

12 month Temporary contract

3 days per week, hybrid based in Euston, London

#LI-CW1

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