Regulatory Professional

AstraZeneca Canada Inc.

• Lead key submission activities, including leading pre-NDS/pre-SNDS meetings, securing accelerated review pathways (Priority Review, Orbis), and preparing high quality dossiers.
• Act as Canadian regulatory lead for major brands in the cardiovascular/renal and oncology (lung, gastrointestinal, women's cancers) therapy areas.
• Support ongoing compliance activities including a GVP audit and inspection, fulfillment of post-authorization commitments, and continual process improvements.
• Improve the capability of the Regulatory Affairs department by mentoring junior staff and providing training to the department on Health Canada / industry updates.

Janssen Inc.

• Led clinical regulatory activities for a clinical SNDS and a clinical/CMC SNDS in oncology, including preparing the submissions, leading Health Canada meetings, and developing clarifax responses.
• Coordinated pre-launch activities with commercial partners to meet business needs, including the review of promotional materials to ensure they meet regulatory and PAAB requirements.
• Acted as the Canadian regulatory representative for new and established oncology products.
• Developed and applied software tools using Python to gather competitive intelligence from publicly-available sources to inform regulatory strategies.

Janssen Inc.

• Prepared small submissions (e.g., NCs) and supported the preparation of an SNDS and NDS, and support negotiations with Health Canada.
• Reviewed literature and clinical data to construct arguments to support a successful priority review request for an NDS.
• Identified key limitations in the analysis of an internal study. Convinced managers and stakeholders of the importance of the limitations, leading to re-assessment of the project and cost-savings for the company.

University of Toronto

• Led a collaboration between four lab members, leading to publication in the Canadian Journal of Psychiatry.
• Analyzed administrative and experimental data from the Bipolar Biobank for a case-control study using R.

Seneca College

University of Toronto

• Investigated a novel inflammatory pathway (NLRP3 inflammasome) as a potential therapeutic target in bipolar disorder using molecular biological techniques.

University of Toronto

• Zhou XY, Fernando SH, Pan AY, Horek N, Laposa R, Keystone E, et al. Characterizing the NLRP3 inflammasome: rationale, technical development and testing of novel methods for assessment of neuropsychiatric disorder pathology. International Journal of Molecular Sciences. November 2021.
• Pan AY, Ryu E, Geske JR, Zhou XY, McElroy SL, Cicek MS, et al. The impact of sample processing on inflammatory markers in serum: Lessons learned. The World Journal of Biological Psychiatry. December 2019.
• Machado AK, Pan AY, da Silva TM, Duong A, Andreazza AC. Upstream pathways controlling mitochondrial function in major psychoses: A focus on bipolar disorder. Canadian Journal of Psychiatry. August 2016.