Regulatory Affairs Specialist Clinical Trials Expert

hace 10 horas

Bogotá, Bogotá D.E., Colombia Igc Pharma Sas A tiempo completo

About IGC Pharma SAS

IGC Pharma SAS is a subsidiary of an NYSE-listed U.S. start-up clinical-stage pharmaceutical company based in Bogota, focusing on preventing and managing Alzheimer's and other CNS diseases.

Role Overview: 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. You will collaborate closely with clinical operations and quality assurance to ensure compliance with global regulatory requirements, including Good Manufacturing Practices (GMP), and prepare regulatory submissions for authorities such as the FDA, EMA, and Health Canada.

Key Responsibilities:

  • Prepare and submit clinical trial regulatory documents to health authorities, including the FDA, EMA, Health Canada, INVIMA, and Institutional Review Boards (IRBs).
  • Ensure compliance with global regulatory requirements for clinical trials, including Good Manufacturing Practices (GMP) and Good Clinical Practice (GCP) standards.
  • Assist in the development and review of Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA).
  • Monitor regulatory changes and updates from global health authorities and communicate these changes to internal teams.
  • Support clinical operations by providing regulatory guidance throughout the study lifecycle.
  • Maintain accurate and up-to-date regulatory files and databases to ensure compliance with record-keeping standards.
  • Contribute to quality assurance audits and inspections of clinical trials and manufacturing processes.

Qualifications:

  • Bachelor's or master's degree in a life sciences-related field (e.g., PharmaD, Pharmacology, Biochemistry, or related discipline).
  • 1-3 years of experience in regulatory affairs, particularly in clinical trials and GMP environments.
  • Strong knowledge of global regulatory guidelines, including FDA, EMA, and Health Canada requirements for clinical trials.
  • Familiarity with GMP and GCP standards.
  • Excellent organizational skills and attention to detail in handling regulatory documentation.
  • Ability to manage multiple projects simultaneously and meet strict deadlines.
  • Strong written and verbal communication skills in English.

Estimated Salary: $80,000 - $110,000 per year, depending on experience and qualifications. This position is based in Bogota, Colombia. Are you a highly talented, collaborative, intelligent, compassionate, committed individual with leadership qualities and a passion for working in healthcare? We want to hear from you.

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