Adriana Stefancic is a strategic Regulatory Affairs and Project Management consultant with over 20 years of experience on global and local projects in the biopharmaceutical, biotechnology, pharmaceutical and generic medicine industries with a consistent record of delivering superior results. Her passion lies in leading and working closely with development and commercialisation teams to successfully progress medicines through complex global regulatory pathways.

Adriana has a track record of success in regulatory processes and approvals with the Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA), Medsafe and an effective working knowledge of European Medicine Agency (EMA) and others. Adriana has demonstrated expertise over the entire drug development process from research and preclinical through clinical development, product licensure, commercialisation and life cycle management for biotechnology, biopharmaceutical, biological and pharmaceutical medicines.

Adriana’s notable career highlights include:

  • Leadership of the regulatory team that prepared and submitted the first Biologics License Application to the FDA for CSL in Australia. FDA licensure was achieved in six months for streamlined product launch and supply in the United States.
  • Project management and leadership of a large cross functional team for a complex and time challenged clinical program for the unexpected 2009 influenza pandemic. Timely FDA and TGA approvals were achieved that enabled conduct of clinical studies in Australia and the United States. The program met the urgent public health need for influenza pandemic vaccine.
  • Achievement of TGA and Medsafe marketing approvals for medicines spanning diverse therapeutic classes that led to new product launches and product supply in Australia and New Zealand, and added to company's commercial product portfolio and the bottom line.
  • Development and implementation of a five-year strategic plan to establish a dedicated team for support of cross functional global activities across Operations and Research & Development.
  • Chairing meetings and negotiation with the FDA, TGA and Medsafe. Achieved agreement on strategies and processes for development programs and regulatory submissions that led to regulatory approvals.

Colleagues have noted that Adriana’s strengths include:

  • A highly focused approach to work and achievement of goals.
  • A global and strategic mindset, and strong business acumen.
  • Being a thought leader of strategies and project plans, and enlisting others on clearly defined pathways and milestones that lead to successful outcomes.
  • A mindset of continuous improvement.
  • Outstanding oral and written communication skills, and a builder of collaborative, credible and long-term relationships.
  • Strong Project Management capabilities.

These are the foundation to her success in achieving global regulatory approvals that lead to clinical trials, product licenses and launches, and optimal life-cycle management.

When not consulting, Adriana’s other passions include spending time with family and friends, travelling the world, experiencing different cultures, learning about interior design, enjoying the arts, taking pleasure in enjoying and cooking diverse cuisines and mentoring others with their careers.

Adriana Stefancic
Principal Consultant: Adriana Stefancic