Senior Regulatory Affairs Specialist UK and Ireland
| Company: | GI Group Main Account |
|---|---|
| Salary: | Not specified |
| Hours: | Full-time |
| Location: | London, WC1B 3HB |
| Working pattern: | Hybrid - 4 days remote |
| Job type: | Temporary |
| Posting date: | 21 Sept 2026 |
| Closing date: | 28 Sept 2026 |
Summary
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
- Manage submissions including
- Partner with Global Regulatory Affairs to deliver
- Support
- Review and approve
- Maintain packaging artwork updates via
- Build strong relationships with
- Monitor regulatory and industry developments and assess business impact.
- Support
- Maintain regulatory files, documentation and databases.
- Provide guidance, training and ad‑hoc regulatory support to internal teams.
UK & Ireland regulatory strategy across POM (including biologics), P and GSL medicines.
MAH transfers, variations, renewals, PSURs/PBRERs.
accelerated approval strategies.
product launches and ongoing product availability.
promotional and non‑promotional materials for regulatory compliance.
Veeva PromoMats.
MHRA and HPRA.
GxP inspections and ensure all products meet regulatory requirements.
Experience & Skills
- Degree in
- Minimum
- Strong experience interacting with
- Deep understanding of
- Excellent attention to detail, documentation quality and cross‑functional collaboration.
- Strong communication, project management and stakeholder engagement skills.
- Fluent in English (written and spoken).
Life Sciences.
5 years' UK & Ireland regulatory experience (pre‑ & post‑approval).
MHRA and HPRA.
post‑Brexit/Windsor Framework regulatory pathways, including the
International Recognition Procedure.
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
Should you require any support or assistance, please contact your local Gi Group office.
Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, corporate members for Neurodiversity in business, Disability Confident committed members, Gold status for the Armed Forces Covenant, Bronze trail blazers for Racial Equality matters and Age Friendly Employer pledge members.
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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