Senior Regulatory Affairs Manager EU post approval
| Dyddiad hysbysebu: | 05 Chwefror 2026 |
|---|---|
| Cyflog: | £70.0 i £90.0 yr awr |
| Gwybodaeth ychwanegol am y cyflog: | £70 - £90 per hour umbrella |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 07 Mawrth 2026 |
| Lleoliad: | Maidenhead, Berkshire, SL6 3UD |
| Cwmni: | Hays Specialist Recruitment |
| Math o swydd: | Cytundeb |
| Cyfeirnod swydd: | 4768385_1770307572 |
Crynodeb
Your new company
Our global biopharmaceutical client is seeking a highly experienced Senior Manager, EU Regulatory Affairs, to lead the EU post‑approval regulatory strategy across a diverse and innovative portfolio. This strategic contract role offers the opportunity to shape EU regulatory direction, drive complex submissions, and act as a key senior representative with Health Authorities and cross‑functional leadership teams.
Your new role
As a senior specialist within the EU Regulatory team, you will take ownership of major regulatory activities supporting both development stage assets and marketed products. Working closely with EU Regulatory Leads and senior leadership, you will influence regulatory strategy, mitigate risks, and ensure ongoing compliance across the product lifecycle.
- Lead the planning, coordination and authoring of major EU regulatory submissions for products in global development and lifecycle management.
- Provide senior level regulatory leadership on global project teams, ensuring alignment across regulatory functions and wider stakeholders.
- Assess regulatory risks, propose mitigation strategies, and influence decision making at senior forums.
- Represent the company with EU and regional Health Authorities, leading preparation for agency meetings and negotiations.
- Guide internal teams on regulatory pathways, scientific requirements and evolving EU regulatory frameworks.
- Monitor regulatory intelligence, anticipate impacts on assigned programs, and drive proactive strategy adjustments.
- Lead and support audit/inspection readiness activities for EU regulatory components.
- Ensure robust post‑approval compliance strategies and execution across assigned projects.
What you'll need to succeed
- Strong understanding of EU legislation, guidelines and compliance obligations across development and post‑approval stages.
- Demonstrated ability to influence senior stakeholders, manage complex projects, and lead multidisciplinary teams.
- Skilled communicator with confidence in representing regulatory positions internally and to Health Authorities.
- Highly organised, detail oriented, and effective in a fast paced, multicultural environment.
What you'll get in return
Remote working with the need to be onsite once or twice per month
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.