Peter Lynch

Peter has more than 25 years of experience in regulatory affairs across government, pharmaceutical, biotechnology, global contract research organisation and consulting environments.

His professional background includes the Therapeutic Goods Administration (TGA), CSL Behring, smaller biotechnology organisations and almost a decade with PPD, where he worked across global and regional regulatory programs and held responsibility for the Australian regulatory team.

Peter's experience extends beyond Australia to international regulatory strategy, development programs, regulatory submissions and interactions with major regulatory authorities. Across his professional career, he has gained regulatory experience involving the Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration (FDA), European Medicines Agency (EMA), and leading regulatory authorities across the Asia-Pacific region. This international perspective informs his understanding of how Australian regulatory requirements interact with global development strategies, evidence packages and regulatory decisions.

Regulatory Experience

Peter's professional experience spans:

• Clinical development and regulatory strategy.
• Australian clinical trials, CTN/CTA and study start-up.
• Australian clinical trial sponsor responsibilities and associated regulatory interfaces.
• Gene technology regulation, OGTR and advanced therapies.
• TGA marketing authorisation, regulatory submissions and agency interactions.
• Product lifecycle management and post-approval regulatory requirements.
• International and Asia-Pacific regulatory programs, including work across multiple regulatory jurisdictions.