Your newpany
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, driveplex 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 ongoingpliance across the product lifecycle.
1. Lead the planning, coordination and authoring of major EU regulatory submissions for products in global development and lifecycle management.
2. Provide senior level regulatory leadership on global project teams, ensuring alignment across regulatory functions and wider stakeholders.
3. Assess regulatory risks, propose mitigation strategies, and influence decision making at senior forums.
4. Represent thepany with EU and regional Health Authorities, leading preparation for agency meetings and negotiations.
5. Guide internal teams on regulatory pathways, scientific requirements and evolving EU regulatory frameworks.
6. Monitor regulatory intelligence, anticipate impacts on assigned programs, and drive proactive strategy adjustments.
7. Lead and support audit/inspection readiness activities for EU regulatoryponents.
8. Ensure robust post‑approvalpliance strategies and execution across assigned projects.
What you'll need to succeed
9. Strong understanding of EU legislation, guidelines andpliance obligations across development and post‑approval stages.
10. Demonstrated ability to influence senior stakeholders, manageplex projects, and lead multidisciplinary teams.
11. Skilledmunicator with confidence in representing regulatory positions internally and to Health Authorities.
12. 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