Oncology Regulatory Expert

17 hours ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €110,000 - €140,000
Regulatory Affairs Lead

We are seeking a talented Regulatory Affairs expert to support our EU regulatory activities for oncology drug development. As a key member of our team, you will contribute to groundbreaking clinical development programs and collaborate with global experts.

A Day in the Life:
  • Develop regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends.
  • Manage CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements.
  • Organize, prepare, and review CTA amendments, annual reports, and other regulatory documents.
  • Perform critical analyses of clinical and preclinical data to develop interpretations and conclusions.
  • Lead EU Scientific Advice requests and coordinate EMA and EU national agency meetings.
Key Requirements:
  • Advanced degree in a scientific discipline.
  • At least 4 years of regulatory experience, with a focus on clinical development.
  • Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
  • Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs.

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