Meet the Team

Overview of Experience

I am a highly accomplished Senior Regulatory Affairs Executive with 30 years’ experience in the pharmaceutical industry, with hands on experience in the development of new products from the ground up and an in depth understanding of the quality standards for pharmaceuticals including GLP and GMP and have extensive knowledge of global pharmaceutical regulation for a broad range of product types (prescription medicines, veterinary, biologics, OTC and medical devices).

I have recent experience in working with Regulators in all the major pharmaceutical markets (US, EU, Canada and Australia), as well as a number of growing markets such as Japan, China and Korea.

Prior to my consulting role, I led a large Regulatory team across the Asia Pacific region and was responsible for the registration and maintenance of in excess of 500 new products and medical devices.

Areas of Expertise

Lesley specialises in the provision of consulting support in the fields of Product Development, Quality and Regulatory Affairs.

Therapeutic Areas of Expertise

I have experience working on both new drugs and biologics in a number of therapeutic areas including Oncology, Dermatology, Nephrology, Inflammatory Diseases, Haematology

Regulatory Bodies of Expertise

Since 2014, I have been an external evaluator for the Australian Therapeutic Goods Administration (TGA) where I am involved in the assessment of applications for new generic medicines, which provides me with a unique understanding of drug registration from the perspectives of both a Sponsor and the Regulator.

Track Record

Some of Lesley’s recent achievements include:

• Preparation of regulatory documentation to support the global registration of a vaccine for SARS-CoV-2.
• Preparation and submission of clinical trial applications in 23 Countries to support a pivotal Phase 3 clinical trial.
• Successful submission of a Phase 3 IND to US FDA with no deficiency questions.
• Establishment of the Regulatory Affairs function for a medium sized pharmaceutical company, including the set up of all regulatory processes and procedures.
• Provision of strategic regulatory advice to support discussions with global regulators such as US FDA, EMA and MHRA.
• Provision of strategic development advice to support the development of a vaccine for Q-fever in goats.
• Preparation of CTD dossiers support registration in Australia.

World first submissions for biosimilar monoclonal antibody products in the EU and Canada and was subsequently registered and launched in more than 30 Countries worldwide.