In my previous role, I was responsible for preparing and submitting various regulatory documents including INDs, NDAs, and annual reports. I have extensive experience with eCTD format and have successfully managed submissions to both the FDA and EMA. My process involves meticulous document organization, ensuring all data meets regulatory standards, and collaborating closely with cross-functional teams to gather necessary information.

I regularly attend industry conferences, participate in webinars, and subscribe to regulatory updates from governing bodies like the FDA and EMA. Additionally, I engage with professional networks and forums to discuss and learn about new regulations and their implications. This proactive approach ensures that I am always prepared to adapt our regulatory strategies to meet new requirements.

I once faced a significant delay in an NDA submission due to a data discrepancy. I quickly organized a cross-functional team to review the data, identified the source of the discrepancy, and worked with the team to correct it. We then prepared a comprehensive response to the FDA, which was accepted, and the submission proceeded without further issues. This experience reinforced the importance of thorough data review and team collaboration.

I prioritize tasks based on deadlines, regulatory impact, and resource availability. I use project management tools to track progress and set milestones. By regularly updating stakeholders and adjusting priorities as needed, I ensure that all projects are completed on time and meet regulatory requirements. This approach helps maintain focus on high-impact activities while managing multiple projects effectively.

Effective communication involves setting clear expectations, providing timely updates, and being approachable. I schedule regular meetings with cross-functional teams to discuss progress, address concerns, and align on objectives. Using collaborative tools like shared documents and project management software helps ensure transparency and accountability. By fostering an open dialogue, I facilitate smoother project execution and timely resolution of issues.