Regulatory and Quality Affairs
Jessica has over 35 years experience in the pharmaceutical industry working in regulatory affairs, clinical research, pharmacovigilance, quality assurance and business development. She started her professional career in regulatory affairs at Abbott and Bayer. From there, she has held senior positions at other well-known companies, including in regulatory affairs, clinical trials and pharmacovigilance in Janssen, quality assurance and manufacturing at Fresenius Medical Care, and Scientific Affairs Director at Apotex. At Apotex, she managed the Regulatory, Pharmacovigilance and QA teams to grow the company from the smallest to the largest generic pharmaceutical company in Australia over 11 years.
She introduced QR codes on pharmaceutical packaging to facilitate the dissemination of patient information leaflets in Australia, working with the TGA to introduce legislation to enable its introduction. This was accelerated by working closely with Guildlink, to introduce digital CMIs and eventually digital PIs. She was also a member of a number of industry working groups, including the TGA IWG, GBMA Regulatory WG, GBMA Biosimilars Core WG and the Electronic Distribution WG, which informed policies and changes to the regulations and guidelines.
Most recently before DMC, Jessica was on the board of the industry association ARCS and a member of the industry advisory group of the science faculty at UTS.