PRINCIPAL CONSULTANT

YOUR CLEAR PATH TO REGULATORY SUCCESS STARTS HERE

Helen Karafotias

Helen brings more than 20 years of regulatory experience across Australia and New Zealand, supporting the registration and commercialisation of innovative pharmaceutical, biological and generic medicines. She is passionate about bringing new therapies to patients in an ethical and timely manner.

Helen’s regulatory and clinical experience spans the preparation and submission of regulatory applications, responses to Therapeutic Goods Administration (TGA) and Medsafe questions, development of comprehensive scientific justifications aligned with regulatory guidance, and support for clinical development programs. Helen is known for her strategic problem‑solving skills and her ability to streamline processes and improve efficiencies within teams.

She has led multiple projects and teams, including heading a local regulatory affairs department, chairing an internal international regulatory working group to pilot a new work‑sharing model across Australia, Canada, Israel, and Switzerland, and driving several initiatives to enhance efficiencies and cross‑functional collaboration.

Helen holds a Bachelor of Science from Monash University and is recognised for her clear communication, strategic insight and consistent delivery of successful regulatory outcomes.

Selected career achievements include:

Led the preparation and management of the Australian submission for the first COVID‑19 treatment during the 2020 global pandemic. Strategic decisions and negotiations contributed to one of the fastest medicine approvals by the TGA—within two weeks of submission—enabling early access to treatment during a critical public health period.

Successfully expedited TGA and Medsafe approvals across multiple therapeutic areas, including CAR T‑cell therapies, supporting access programs and timely commercial launches.

Independently updated key Module 2 and 5 components using current clinical data when only an outdated US sNDA and limited global SME support were available. The TGA approved the submission with minimal questions and no major changes to the Australian Product Information. The updated dossier was subsequently submitted in other regions to gain regulatory approvals.

Supported the setup and conduct of a pivotal European Phase 3 clinical study, including pre-study visits across multiple countries and interpretation of ICH guidelines.

Outside of work, Helen enjoys relaxing at the beach, discovering new adventures with her young family, and sharing delicious meals with family and friends.