Anthea Downs

Anthea Downs has a diverse background in regulatory affairs and consulting within the medical and healthcare industry. Anthea is currently employed as a Senior Regulatory Scientist at Platypus MedTech Consulting since October 2022. Prior to this, they held the position of Chief Regulatory Officer at Neurotologix starting from March 2022.

Anthea has also worked as a Regulatory Affairs Consultant at CBD THERAPEUTICS from January 2016, where they provided regulatory strategy advice and compiled regulatory documentation for various medical devices and medicines. Anthea also managed existing product approvals and provided technical support for regulatory submissions.

At Nuheara, Anthea worked as a Regulatory Affairs Manager from January 2022 to May 2022. Anthea developed an ISO 13485-compliant Quality Management System and provided regulatory support for FDA, TGA, and EU submissions.

Prior to that, Anthea served as the Head of Regulatory Affairs at Little Green Pharma from July 2021 to December 2021. In this role, they provided expert advice on the regulatory requirements for the legal supply of medicinal cannabis products.

Anthea also has experience as the Director of Regulatory Affairs at Orthocell Ltd from January 2018 to January 2020. Anthea developed regulatory strategies and prepared regulatory documentation for the approval of medical devices and cellular therapies.

Before their role at Orthocell, Anthea worked as a Senior Regulatory Affairs Associate at PFIZER AUSTRALIA PTY LTD from January 2015 to December 2015. Anthea managed existing product registrations and ensured compliance with local and international standards.

Anthea's career started at ADMEDUS LTD, where they served as a Technical Manager and Regulatory Affairs Associate from January 2013 to December 2014. Anthea provided regulatory support for FDA submissions and prepared non-clinical study reports.

Their earlier experience includes working at the Therapeutic Goods Administration as a Director from January 2007 to January 2013. In this role, they conducted scientific evaluations and managed regulatory submissions for medical devices, medicines, and cellular therapy products.

Overall, Anthea Downs has demonstrated expertise in regulatory affairs, including strategy development, documentation preparation, compliance management, and submission support. Anthea has experience in various sectors of the medical and healthcare industry, including pharmaceuticals, medical devices, cellular therapies, and cannabis products.

Anthea Downs completed a Bachelor of Science (BS) degree at Macquarie University. Later, they pursued and obtained a Doctor of Philosophy (PhD) degree at The University of Western Australia.