Fasalu R. - 16647 Regulatory Affairs Associate from Toronto

Skilled in handling aseptic techniques, pipetting, and serial dilution procedures and have knowledge of Biosafety practices and tools in a Containment level 2 laboratory. • 5 Years of combined academic and industrial experience in Biotechnology, Biochemistry, Microbiology and Genetics labs with practical knowledge in HACCP, GLP, GMP, and SOP. • Thorough knowledge of ICH-GCP Guidelines and understanding of local regulatory requirements. • Have a thorough understanding of the Serious Adverse Event (SAE) reporting procedure, including the creation of reports, narratives, and SAE follow-up. • Familiarity with medical and/or scientific terminology. • Project management and strong prioritization skills. • Ability to synthesize information from a body of literature and analyze quantitative data. • Proficient with MS Office Word, Excel, Outlook, PowerPoint, FASTA and BLAST, and LIMS. • Sound independent judgment and competence in research methodologies. • Excellent customer service, communication, interpersonal, and organizational skills with high attention to detail.