Oncology Regulatory Strategy Lead

19 hours ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €106,000 - €136,000

Job Overview

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We are seeking a seasoned Regulatory Affairs Manager to support EU regulatory activities for oncology drug development.

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This strategic role will involve developing and executing regulatory strategies, managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements.

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The ideal candidate will possess an advanced degree in a scientific discipline and at least 4 years of regulatory experience, with a focus on clinical development.

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Key Responsibilities:

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  • Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends.">
  • Managing CTA submissions, ensuring compliance with EU regulations.">
  • Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents.">
  • Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions.">
  • Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings.">
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Requirements:

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  • An advanced degree in a scientific discipline.">
  • At least 4 years of regulatory experience, with a focus on clinical development.">
  • Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs.">
  • Experience in oncology regulatory strategy is an advantage.">
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What We Offer

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A challenging opportunity to contribute to the development of oncology treatments and enhance your skills and expertise in regulatory affairs.

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Contact Information

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