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.
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* Managing CTA submissions, ensuring compliance with EU regulations.
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* Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents.
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* Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions.
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* 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.
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* At least 4 years of regulatory experience, with a focus on clinical development.
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* Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs.
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* 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