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Regulatory Compliance Expert

hace 3 semanas

Almería, Almería, España Precision For Medicine A tiempo completo
Regulatory Manager Job Description

Precision for Medicine is seeking a highly skilled Regulatory Manager to provide strategic guidance on regulatory compliance, ensuring the optimal conduct of clinical trials and successful interactions with regulatory authorities.

Key Responsibilities:
  • Offer expert regulatory guidance throughout the clinical development life cycle to ensure compliance with applicable regulations.
  • Compile, coordinate, and review applications to Regulatory Authorities, including 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 guarantee compliance with regulatory standards.
  • Represent Global Regulatory Affairs at project team meetings with both external and internal customers.
  • Collaborate within a project team and lead projects as necessary for the region or globally.
Qualifications:
  • Bachelor's degree in a scientific or healthcare discipline, or equivalent experience.
  • Minimum 5 years of Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level.
  • In-depth knowledge of all aspects of the drug development process, including regulatory milestones, and specialized knowledge of regulatory activities for at least one major region (EU, US).
Requirements:
  • Regulatory affairs experience working for a Clinical Research Organisation.
  • Experience leading Clinical Submissions.
  • Able to understand clinical and pre-clinical study results, to help inform regulatory positions and strategy.
Preferred Skills:
  • Familiarity with clinical trials methodology, including a working knowledge of protocols and indications being studied.
  • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.

Precision for Medicine is a growing organization serving our clients researching groundbreaking cancer therapies. We strive to ensure employees feel valued and appreciated for their contributions every day.