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Senior Regulatory Manager Oncology (EU Development)Location: UK Your new company Join a leading global biotechnology company 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 role As Senior Regulatory Manager, you will lead the […]
Senior Regulatory Manager Oncology (EU Development)Location: UK
Your new company
Join a leading global biotechnology company 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 role
As Senior Regulatory Manager, you will lead the EU regulatory strategy for oncology products in development. Working cross-functionally with global teams, you will:
- Develop and execute regulatory strategies for oncology assets in the EU.
- Lead regulatory submissions including CTA, MAA, and scientific advice procedures.
- Serve as the primary EU regulatory contact for internal stakeholders and health authorities.
- Provide strategic input into clinical development plans, ensuring alignment with EU regulatory requirements.
- Monitor changes in the regulatory landscape and assess their impact on product development.
- Collaborate with cross-functional teams including clinical, medical, safety, and commercial.
What you’ll need to succeed
- Strong knowledge of EU regulatory requirements and procedures (EMA, national agencies).
- Experience with oncology products and clinical development phases.
- Proven ability to lead regulatory strategy and manage complex submissions.
- Excellent communication, project management, a
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