Adriana Stefancic brings over 30 years of global regulatory experience across biopharmaceuticals, biotechnology, pharmaceutical and vaccine products.

She has successfully led regulatory programs engaging the FDA, TGA, EMA, Medsafe and other regulatory agencies, covering the full product lifecycle from early development to commercialisation.

Selected Career Highlights

• Regulatory lead for COVID-19 vaccine approvals (AU/NZ) during the global pandemic.
• Led the first FDA BLA for CSL, achieving approval in 6 months following accelerated review.
• Co-led regulatory strategy for pandemic influenza programs, enabling rapid IND and CTA approvals.
• Secured TGA and Medsafe approvals for multiple medicines across diverse therapeutic areas.
• Advised on FDA 505(b)(2) pathway for oncology product development.
• Chaired meetings and negotiated with regulatory agencies to achieve successful outcomes.
• Designed and delivered bespoke training program on therapeutic legislation (AU/NZ) and CTD Modules to strengthen regulatory capability.

Approach

Adriana collaborates closely with clients to:

• Navigate complex regulatory challenges
• Build aligned, high-performing teams
• Deliver successful approvals and commercial outcomes

All consulting services are delivered personally by Adriana, ensuring senior-level expertise and direct engagement.