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Describe your experience in developing and executing global regulatory strategies for small molecules and combination products. Please include examples of early and late development stages.
Provide an example of a regulatory challenge you anticipated in a previous role and explain how you developed a mitigation strategy in collaboration with clinical, CMC, and nonclinical functions.
Explain your approach to leading the authoring, review, and submission of key regulatory documents, including INDs, CTAs, briefing books, and response packages. Include details on ensuring alignment with program milestones and strategic objectives.
Describe your experience in building and managing a high-performing regulatory team, including internal staff and external partners. How do you ensure operational excellence within your team?