Regulatory Affairs Specialist Clinical Trials & GMAbout the Company: IGC Pharma SAS is based in Bogota and is a subsidiary of an NYSE-listed U.S. start-up clinical-stage pharmaceutical company that focuses on preventing and managing Alzheimer's and other CNS diseases.
We also develop, manufacture, and market over-the-counter products for women's health.
We are an exciting, young, diverse workplace with excellent benefits.
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.Preferred Qualifications: Experience preparing and submitting regulatory documents to health authorities.Knowledge of investigational product development processes and clinical trial regulations.This position is based in Bogota.
Are you a highly talented, collaborative, intelligent, compassionate, committed, well-traveled, self-driven individual with leadership qualities, a passion for working in health care, and driven by numbers?
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