-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.

Collaborated extensively with the Regulatory Affairs team and engaged in cross-functional meetings to ensure seamless regulatory submissions, fostering effective communication among local and global stakeholders such as Product Development Regulatory, Pharma Technical Regulatory, and GxP.Formulated a robust regulatory strategy document to guide the development of new products in the US market, encompassing Pre-Clinical, IND filing, Human Experimentation, NDA filing, and Pharmacovigilance stages, ensuring compliance with relevant guidelines and regulations.Collaborated with cross-functional teams to address quality issues, implementing Corrective and Preventive Actions (CAPA) for continuous improvement. Contributed to the development and revision of SOPs, enhancing operational efficiency and maintaining consistent quality standards. Identified root causes of non-conformances, deviations, and complaints, implementing effective solutions to address and resolve issues Participated in the review, approval, and accurate documentation of batch records, changed control requests, and other quality-related documents. Applied strong problem-solving skills in supporting investigations and resolutions, minimizing risks and maintaining a proactive approach to quality issues