Gi Group
Senior Regulatory Affairs Specialist UK and Ireland
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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.
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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).
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Behavioural Competencies
- Consumer and patient-focused.
- Collaborative and open communicator.
- Innovative and proactive.
- Delivers high-quality, right-first-time outcomes.
Job Details
- 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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