Senior Regulatory Affairs Specialist UK 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.

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

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Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.

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