At a Glance
- Tasks: Lead regulatory strategy and manage submissions for medicinal products and devices in the UK & Ireland.
- Company: Join a leading pharmaceutical organisation specialising in Dermatology.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with strong focus on innovation and quality outcomes.
- Why this job: Make a real impact on product launches and compliance in a dynamic industry.
- Qualifications: Degree in Life Sciences and 5+ years of regulatory experience required.
The predicted salary is between 60000 - 75000 £ per year.
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 Promo Mats.
- Build strong relationships with MHRA and HPRA.
- Monitor regulatory and industry developments and assess business impact.
- Support Gx P 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.
Working Hours: Monday to Friday, 37.5 hours per week.
Contract: 12 month Temporary contract. Hybrid based in Euston, London (3 days per week).
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