Yong Z. - 16413 Regulatory Affairs Analyst from Toronto

Ph.D. graduate with 12 years of research experience. Knowledgeable about a wide range of research methods, scientific methodologies and statistics. Adept at data management, analysis, interpretation, summary and presentation. Well-versed in technical writing and communication. Capable of conducting proof-of-concept studies and undertaking projects independently. Worked as a quality assurance intern in a pharmaceutical company to help facilitate product release by requesting, reviewing and filing release documents. Contributed to departmental regulatory compliance by organizing, updating and maintaining quality and compliance documents such as Standard Operating Procedures and training logs. Participated in audits and product recalls. Developed a good understanding of the drug and medical device regulations in Canada. Gained exposure to evaluation of post-NOC changes, review of labels and preparation of responses to Health Canada requests. Familiar with the CTD format and DEL, DINA and NDS submissions. Detail-oriented with great project management and problem-solving skills.