Global Regulatory Affairs Lead: EMA Strategy & Submissions

Biogen; Maidenhead; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A global biotechnology leader is seeking a Senior Manager for Global Regulatory Affairs in Maidenhead, UK. This hybrid role requires about 50% office presence, overseeing regulatory submissions and guiding strategic direction for projects. The ideal candidate will have significant experience in regulatory affairs within the pharmaceutical industry, with strong leadership and communication skills to foster collaboration across teams. Join a dynamic environment to maintain ethical and regulatory standards and support the global clinical development lifecycle.

Qualifications

• Proven experience in pharmaceutical/biotech industry, especially in Regulatory Affairs.
• Hands-on experience with EMA regulatory filings.
• Experience interacting with regulatory authorities, such as the EMA.

Responsibilities

• Collaborate with the Global Regulatory Lead for assigned projects.
• Identify and assess regulatory risks and define mitigation strategies.
• Lead the EU regulatory submission process.

Skills

Leadership

Communication

Regulatory Affairs Strategy

Problem Solving

Analytical Skills

Education

Degree in Life Science or related discipline

Job description

A global biotechnology leader is seeking a Senior Manager for Global Regulatory Affairs in Maidenhead, UK. This hybrid role requires about 50% office presence, overseeing regulatory submissions and guiding strategic direction for projects. The ideal candidate will have significant experience in regulatory affairs within the pharmaceutical industry, with strong leadership and communication skills to foster collaboration across teams. Join a dynamic environment to maintain ethical and regulatory standards and support the global clinical development lifecycle.