Regulatory Affairs Specialist

hace 3 semanas


Madrid, Madrid, España Precision Medicine Group A tiempo completo

About Us

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Precision Medicine Group is a leading Clinical Research Organisation that brings together new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients.

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Our team has a strong focus on Oncology and Rare Disease, and we're seeking a Regulatory Manager to join our team. The role will be based in the UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland.

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Job Summary

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We're looking for a highly experienced Regulatory Manager to provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.

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The successful candidate will have 5 years of Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level. You'll need to be fluent in English and have a Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.

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Key Responsibilities

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As a Regulatory Manager, you'll:

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  • Provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.">
  • Compile, coordinate, and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.">
  • Develop and/or review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.">
  • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers.">
  • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.">
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Qualifications

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To be considered for this role, you'll need:

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  • A Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.">
  • 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level.">
  • Fluency in English.">
  • Computer literacy (MS Office/Office 365).">
  • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.">
  • Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy.">
  • Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.">
  • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.">
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Estimated Salary: £60,000 - £80,000 per annum

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Location

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UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland.

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About the Role

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This is a fantastic opportunity to join a leading Clinical Research Organisation and contribute to the development of life-changing therapies.

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As a Regulatory Manager, you'll have the chance to work with a talented team, develop your skills and expertise, and make a real impact on the lives of patients.

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Contact Us

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If you're passionate about Regulatory Affairs and want to join a dynamic team, please submit your application.

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We are an Equal Opportunities Employer

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We welcome applications from diverse candidates and are committed to creating an inclusive workplace culture.



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