I have over five years of experience drafting and reviewing regulatory documents, including clinical study reports, investigator brochures, and submission documents for FDA and EMA. My expertise lies in ensuring compliance with ICH-GCP guidelines and local regulatory requirements, translating complex clinical data into clear, regulatory-compliant content. This experience has honed my ability to work collaboratively with cross-functional teams to meet tight deadlines without compromising quality.

I regularly attend webinars and workshops hosted by regulatory bodies like the FDA and EMA, and subscribe to industry newsletters such as the Regulatory Affairs Professionals Society (RAPS). I also participate in professional forums and online communities where peers discuss updates and interpretations of new guidelines, ensuring my knowledge remains current and applicable to my work.

One challenging project involved preparing a comprehensive response to an FDA query within a two-week deadline. The query required detailed analysis of clinical data and justification of our methodology. I led a team to consolidate inputs from various departments, ensuring the response was scientifically robust and regulatory compliant. Our successful submission resulted in the approval of the application, demonstrating my ability to manage high-pressure projects effectively.

I employ a meticulous review process, including cross-checking data against source documents, using templates and checklists to ensure all regulatory elements are addressed, and seeking feedback from subject matter experts. Additionally, I utilize document management systems to track revisions and maintain version control, ensuring the final document is accurate and meets all regulatory standards.

When encountering discrepancies, I first verify the data against original source documents to identify the root cause. I then collaborate with the clinical team to resolve any inconsistencies, documenting the process and rationale for any changes made. This approach ensures transparency and maintains the integrity of the submission, aligning with regulatory expectations for accuracy and completeness.