PRINCIPAL CONSULTANT

YOUR CLEAR PATH TO REGULATORY SUCCESS STARTS HERE

Helen Karafotias

Helen has over 20 years experience in the regulatory environment in Australia and New Zealand, registering and supporting the commercialisation of biological and innovative pharmaceutical and generic medicines.

Helen is passionate about bringing new medicines and therapies to patients in an ethical and timely manner. Helen’s clinical experience includes but is not limited to creating responses to the Therapeutic Goods Administration (TGA) and Medsafe questions, creating comprehensive justifications to meet regulatory guidance's, she has supported the clinical development of life saving medicines and been involved in the preparation and submission of regulatory appeals. Helen is a strategic problem solver brought in to solve complex problems and improve efficiencies within teams.

She has led multiple projects and teams that have included, leading the local regulatory affairs department as the Regulatory Affairs Head, she has lead an international regulatory affairs working team to pilot a new worksharing process between teams in Australia, Canada, Israel and Switzerland and has lead multiple projects to improve efficiencies within regulatory affairs.

Helen has a Bachelor of Science from Monash University and has spent her career leading projects in regulatory affairs with a magnitude of success.

Selected career achievements include:

Preparation and management of the Australian submission to register the first treatment option for COVID-19 during the global pandemic in 2020. These strategic decisions and negotiations resulted in one of the fastest regulatory approvals of a medicine by the TGA – within 2 weeks of the receipt of the submission. This lead to early access of product, supporting the urgent public health need for Australians in the early days of the pandemic.

Achievements in successfully expediting TGA and Medsafe marketing approvals of medicines in different therapeutic areas, including CAR T-cell therapies to support access programs and timely commercial launches.

With only an outdated US sNDA available, and limited global subject matter expert support, Helen conducted a literature search and updated the relevant module 2 and 5 components, with more current clinical data. The submission was approved by the TGA with minimal questions or changes to the Australian Product Information. This updated dossier was subsequently submitted in other regions where the indication was also approved.

Supporting the activities associated with the set up and conduct of an Investigator’s Meeting for the roll out of the pivotal European Phase 3 clinical study. This involved understanding and communicating ICH guidelines and conducting several pre-study start up visits in Athens (Greece), London (UK), Zurich (Switzerland), Besancon (France) and Amsterdam (Netherlands).

When not working, Helen enjoys relaxing at the beach, finding new adventures to help occupy her young family and catching up for delicious meals with family and friends.