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Regulatory Affairs Coordinator

2 weeks ago

Copenhagen, Copenhagen, Denmark IQVIA Argentina Full time

Job Title: Regulatory Affairs Coordinator

IQVIA Argentina is seeking a highly skilled Regulatory Affairs Coordinator to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, providing training and support to sites, and collaborating with the study team to track the progress of assigned studies.

Key Responsibilities:

  • Ensure compliance with regulatory requirements, such as GCP and ICH guidelines.
  • Provide training and support to sites to ensure adherence to protocol and regulatory requirements.
  • Collaborate with the study team to track the progress of assigned studies.
  • Evaluate the quality and integrity of study site practices and identify areas for improvement.
  • Establish and maintain effective working relationships with coworkers, managers, and clients.

Requirements:

  • Bachelor's Degree in a scientific discipline or health care preferred.
  • At least 2 years of experience in regulatory affairs or a related field.
  • Good knowledge of clinical research regulatory requirements, GCP, and ICH guidelines.
  • Excellent communication, organizational, and problem-solving skills.
  • Ability to establish and maintain effective working relationships.