Sample interview questions: Can you describe your experience in managing regulatory submissions for orphan drug designations and expedited review programs?
Sample answer:
- Managed regulatory submissions for orphan drug designations and expedited review programs for various pharmaceutical and biotechnology companies.
- Served as the primary regulatory contact for orphan drug and expedited review submissions, interacting with regulatory agencies such as the FDA, EMA, and PMDA.
- Prepared and submitted orphan drug and expedited review applications, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
- Developed and implemented regulatory strategies for orphan drug and expedited review programs, considering factors such as the disease’s rarity, unmet medical need, and the potential benefit-risk profile of the drug.
- Collaborated with cross-functional teams, including clinical development, nonclinical development, and quality assurance, to ensure the timely and accurate completion of regulatory submissions.
- Coordinated responses to regulatory inquiries and requests for information, working closely with internal subject matter experts to provide comprehensive and timely responses.
- Monitored regulatory changes and updates, ensuring that regulatory subm… Read full answer
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