In a previous role, I was tasked with ensuring our clinical trial adhered to FDA regulations. I meticulously reviewed all documentation, coordinated with cross-functional teams, and conducted regular audits to identify and address any potential non-compliance issues. This proactive approach not only ensured our trial's integrity but also streamlined the submission process, resulting in timely approval.

I regularly attend industry conferences, subscribe to regulatory newsletters, and participate in professional associations to stay informed about the latest changes. Additionally, I engage in continuous learning through online courses and webinars, ensuring that my knowledge remains current and relevant to the evolving regulatory landscape.

My process involves a thorough review of all clinical documents against established regulatory guidelines and internal standards. I start by understanding the document's purpose and scope, then conduct a detailed review for accuracy, completeness, and compliance. Any discrepancies are flagged for revision, and I work closely with the authors to ensure the final document meets all requirements before approval.

When conflicts arise, I prioritize regulatory compliance to ensure patient safety and legal adherence. I then work collaboratively with stakeholders to find a balanced solution that aligns with both regulatory standards and business goals. This often involves proposing alternative strategies or modifications to the project plan to achieve compliance without compromising the overall objectives.

I have extensive experience preparing and submitting regulatory documents, including IND, NDA, and MAA applications. One significant challenge I faced was managing the submission timeline while ensuring all data was accurate and complete. To overcome this, I implemented a detailed project plan with clear milestones and frequent check-ins with the team, which helped us meet deadlines without compromising the quality of the submission.