Regulatory Affairs Associate
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I am a recent graduate looking to break into the Regulatory Affairs/ Quality Assurance field. I have deep understanding of Health Canada, FDA regulations for pharmaceuticals and medical devices.
have worked as a Lab Analyst and Quality Assurance Associate in the pharmaceutical industry, where I supported laboratory testing, GMP compliance, documentation, and quality checks
I completed a Master of Science in Regulatory Affairs, where I gained in-depth knowledge of pharmaceutical and medical device regulations, quality management systems (including ISO 13485 and GMP), regulatory documentation and forms, product registration and approval processes, clinical trial design and submission requirements, labeling and safety compliance, risk management, post-market surveillance, pharmacovigilance, global regulatory frameworks (Health Canada, FDA, EMA, ICH), and practical experience with preparing regulatory submissions and dossiers. The program also taught me how to interpret regulatory guidance, ensure compliance throughout the product lifecycle, and support cross-functional teams in regulatory and quality activities.