Senior Regulatory Manager Oncology (EU Development)Location: UK. 1 day on site per month
Your newpanyJoin a leading global biotechnologypany at the forefront of innovation in oncology. With a strong pipeline, this organisation is expanding its regulatory team to support the development of oncology products across the EU region.
Your new roleAs Senior Regulatory Manager, you will lead the EU regulatory strategy for oncology products in development. Working cross-functionally with global teams, you will:
1. Develop and execute regulatory strategies for oncology assets in the EU.
2. Lead regulatory submissions including CTA, MAA, and scientific advice procedures.
3. Serve as the primary EU regulatory contact for internal stakeholders and health authorities.
4. Provide strategic input into clinical development plans, ensuring alignment with EU regulatory requirements.
5. Monitor changes in the regulatory landscape and assess their impact on product development.
6. Collaborate with cross-functional teams including clinical, medical, safety, andmercial.
What you'll need to succeed
7. Strong knowledge of EU regulatory requirements and procedures (EMA, national agencies).
8. Strong experience with PIPs, Scientific Advice, ODD's – you will need to be able to explain your expertise in interview on these topics.
9. Experience with innovative products and clinical development phases.
10. Proven ability to lead regulatory strategy and manageplex submissions.
11. Excellentmunication, project management, and stakeholder engagement skills.
What you'll get in return
12. The chance to lead regulatory strategy for high-impact oncology programs.
13. A collaborative, global team environment with strong scientific and clinical expertise.