Sample interview questions: Can you discuss your experience in managing regulatory affairs for medical research projects involving gastrointestinal disorders or microbiome-based therapies?
Sample answer:
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Experience in managing regulatory affairs for medical research projects involving gastrointestinal disorders or microbiome-based therapies:
- Led the regulatory strategy and submission process for a Phase II clinical trial evaluating the safety and efficacy of a novel microbiome-based therapy for inflammatory bowel disease (IBD). Successfully obtained Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) and local regulatory authorities in multiple countries.
- Coordinated with clinical research teams to ensure compliance with regulatory requirements throughout the trial, including protocol development, patient recruitment, data collection, and adverse event reporting.
- Developed and implemented a comprehensive regulatory strategy for a Phase III clinical trial evaluating the efficacy and safety of a new drug for the treatment of gastroesophageal reflux disease (GERD). Worked closely with the clinical team to address regulatory concerns and ensure compliance with Good Clinical Practice (GCP) guidelines.
- Successfully obtained marketing authorization for a new drug for the treatment of Crohn’s disease in the European Union (EU) through the centralized procedure. Led the preparation and submission of the Marketing Authorization Application (MAA) and coordinated with the European Medicines Agency (EMA) during the review process.
- Managed the regulatory pathway for a microbiome-based therapy for the treatment of irrita… Read full answer
Source: https://hireabo.com/job/2_3_19/Regulatory%20Affairs%20Specialist