Regulatory Affairs Intern
-Project - NDS SubmissionPerformed tasks over 3 months of supervised internship:• Successfully prepared various submission documents and used the CTD backbone to meet Health Canada's validation criteria for the preparation of CTD submissions, ensuring full compliance with the Canadian and International regulatory standards.• Interpreted and applied ICH-M4, and Health Canada's regulations, guidance documents, and policies, and used them to effectively prepare, compile, and format regulatory documents in accordance with regulatory guidelines.• Demonstrated a comprehensive understanding of CTD requirements for Health Canada, enabling the development of a Regulatory Strategy for optimally preparing NDS in CTD format for submission to Health Canada.• Collaborated effectively within the team to coordinate the compilation of necessary documentation, ensuring seamless information exchange and timely completion of regulatory submissions.• Proactively acquired and applied Regulatory Project Management skills, including the utilization of tools such as Gantt charts, to ensure efficient planning and execution of submissions in CTD format, resulting in streamlined processes and timely deliverables.
