This question is asked to evaluate your familiarity with the regulatory frameworks and compliance standards that govern drug development. When answering, highlight specific regulations (such as FDA, EMA, or other relevant bodies), your experience with submitting regulatory documents, and any involvement in compliance audits or inspections. Provide concrete examples of how you have ensured compliance in past projects, and emphasize your understanding of the importance of these regulations in ensuring drug safety and efficacy.
Example: "In my previous role at XYZ Pharma, I was responsible for ensuring that our drug development processes adhered to FDA regulations. I prepared and submitted IND and NDA documents, and worked closely with regulatory agencies to address any concerns. Additionally, I led internal audits to ensure ongoing compliance and participated in external inspections, which resulted in successful approvals without major findings."
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