Regulatory Affairs Specialist Clinical Trials

hace 2 días

Bogotá, Bogotá D.E., Colombia Clínica Colombia ES A tiempo completo
About the Position

Clínica Colombia ES is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the successful planning and execution of clinical trials and the regulatory approval of new drugs.

Key Responsibilities:
  1. Regulatory Document Preparation: Prepare and submit clinical trial regulatory documents to health authorities, including the FDA, EMA, and Health Canada.
  2. Regulatory Compliance: Ensure compliance with global regulatory requirements for clinical trials, including Good Manufacturing Practices (GMP) and Good Clinical Practice (GCP) standards.
  3. Regulatory Submissions: Assist in the development and review of Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA).
  4. Regulatory Monitoring: Monitor regulatory changes and updates from global health authorities and communicate these changes to internal teams.
  5. Regulatory Guidance: Support clinical operations by providing regulatory guidance throughout the study lifecycle.
  6. Regulatory File Maintenance: Maintain accurate and up-to-date regulatory files and databases to ensure compliance with record-keeping standards.
  7. Quality Assurance: Contribute to quality assurance audits and inspections of clinical trials and manufacturing processes.
Requirements:
  1. Education: Bachelor's or master's degree in a life sciences-related field (e.g., PharmaD, Pharmacology, Biochemistry, or related discipline).
  2. Experience: 1-3 years of experience in regulatory affairs, particularly in clinical trials and GMP environments.
  3. Knowledge: Strong knowledge of global regulatory guidelines, including FDA, EMA, and Health Canada requirements for clinical trials.
  4. Skills: Excellent organizational skills and attention to detail in handling regulatory documentation.
  5. Communication: Strong written and verbal communication skills in English.

The position is located in Bogota, Colombia. It is essential to have a valid U.S. Visa or be in the process of obtaining one.

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