Kelly specialises in commercial disputes and investigations, with particular expertise in regulatory and law enforcement investigations. Prior to joining Gadens, Kelly worked at two top-tier Australian law firms, in the enforcement team at the Australian Securities and Investments Commission (ASIC), and as Chief Legal Counsel and Head of Government Affairs and Policy for one of the world’s largest biopharmaceutical companies.
She advises clients operating in highly regulated industries, including financial services, healthcare, biotechnology, pharmaceuticals, energy and resources, FMCG, manufacturing, telecommunications, transport (aviation, heavy vehicles, rail) and technology. Kelly represents her clients in investigations and court proceedings undertaken by Australia’s peak regulators including ASIC, AFCA, ACCC, AFP, AUSTRAC, Border Force, TGA, APVMA, OAIC, the Ombudsman, transport safety regulators, the Aged Care Quality and Safety Commission, NDIS Quality and Safeguards Commission and the Professional Services Review agency (Medicare and PBS investigations). Kelly acts for the Australian Health Practitioner Regulation Agency in respect of its investigations and enforcement functions. Kelly also has experience advising on multijurisdictional investigations, including by the US Department of Justice, the UK Serious Fraud Office and the US FDA.
In addition, Kelly has deep expertise in government inquiries, including advising clients appearing before Royal Commissions and other Parliamentary inquiries. This includes advising clients on public policy strategies and preparing submissions in connection with proposed legislative reform and related advocacy. Kelly was a member of the Medicines Australia taskforce responsible for negotiating and implementing the 2018 Strategic Agreement, and associated legislative amendments, between the innovative medicines industry and the Federal Government.
Kelly also acts in a range of general commercial disputes including contractual disputes, shareholder disputes, Corporations Act matters (including insider trading, market manipulation, Chapter 7 and other disciplinary matters), advertising disputes, consumer law, intellectual property, product liability, tort and administrative law actions.
She provides strategic advice in relation to financial services regulation, healthcare regulation, public sector accountability, anti-bribery and corruption, therapeutic goods regulation, chemicals regulation, sanctions compliance and government procurement. This has included strategic advice on submissions to Advisory Committee on Chemicals Scheduling, Advisory Committee on Medicines Scheduling, Medical Services Advisory Committee and the Pharmaceutical Benefits Advisory Committee.
Kelly is an experienced company director in the healthcare and creative arts industries and is a member of the Human Research Ethics Committees of the Royal Children’s Hospital and Murdoch Children’s Research Institute. Kelly is also a member of the Advisory Council to the Victorian Health Complaints Commissioner (by Ministerial appointment), as well as being a member of the Regulatory Affairs Working Group of the Consumer Healthcare Products Association. Kelly is also a member of the Presumptive Rights Advisory Committee, for Emergency Management Victoria and WorkSafe Victoria, also by Ministerial appointment.
Kelly is the legal expert for LexisNexis in relation to its training modules and compliance solutions on therapeutic goods regulation.
Kelly is recognised as a Best Lawyer in the area of Litigation by Best Lawyers Australia.