Regulatory Affairs Coordinator Senior

hace 3 semanas


Barcelona, Barcelona, España ICON A tiempo completo
About Us

At ICON, we pride ourselves on fostering an inclusive environment driving innovation and excellence. We welcome talented individuals to join our mission to shape the future of clinical development.

About the Job:

We are seeking a highly skilled Regulatory Affairs Coordinator Senior to lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.

Your Key Responsibilities:

  1. Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
  2. Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
  3. Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
  4. Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your Skills and Qualifications:

  • Bachelor's degree in life sciences or a related field.
  • Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
  • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
  • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
  • Fluency in English and Spanish.

Benefits and Compensation:

  • A competitive salary of $65,000 - $85,000 per year, depending on location and experience.
  • A range of benefits, including various annual leave entitlements, health insurance offerings, retirement planning options, and flexible country-specific optional benefits.


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