Shaily Arora

About Shaily Arora

Dr. Shaily Arora, is a distinguished global leader in oncology drug development, leading global regulatory strategy for the Breast Cancer portfolio and driving integrated clinical evidence strategies to maximize asset value and long-term commercial performance across ADCs, biologics, and small molecules.Her accomplished career is defined by her significant and long-standing influence on FDA policy and regulatory science, stemming from a variety of roles held at the Food and Drug Administration (FDA). Notably, during her tenure as a Clinical Reviewer on the Breast and Gynecologic Malignancies Team, she oversaw critical INDs, NDAs, and BLAs.Dr. Arora was instrumental in establishing and shaping two foundational, globally influential oncology policy reforms:• Project Optimus: She was a founding member of this initiative, which established new standards for optimal dose selection in cancer drug development. Continuing this commitment at AstraZeneca, she established and co-chairs the Dose Optimization Working Group and has presented on this topic at various national and international conferences.• Project Orbis: She played a pivotal role in the launch of this global collaboration framework, which led the first collaborative review of oncology products among international regulatory partners.Her experience spans over two decades in leadership roles across government, industry, and academia, focusing on translating complex regulatory science into actionable strategies that accelerate transformative therapies to patients worldwide. Dr. Arora’s contributions are recognized through prestigious honors, including the 40 under 40 Award from CSU East Bay and the Alumni Early-Career Award from UCSF.

Experience

1. Executive Director, Oncology Regulatory Strategy

   阿斯利康

   Jul 2021 — Present · US

   Deliver strategic leadership across multiple oncology disease areas, driving the development and execution of global regulatory strategies from Phase I to IV, ensuring alignment with AstraZeneca’s vision and priorities.• Shape and execute oncology global regulatory policies, championing the company’s regulatory vision, goals, and initiatives.• Build and nurture strong partnerships with internal stakeholders to enable decisive, strategic development and commercial decision-making.• Lead regulatory innovation by analyzing complex intelligence, emerging science, competitive trends, and global regulatory shifts, ensuring strategies remain agile and forward-looking.• Provide critical oversight and guidance on clinical programs, influencing study designs, registration strategies, data analysis, and risk mitigation to ensure successful outcomes.• Represent Global Regulatory Affairs at the highest levels, including senior leadership committees, health authority meetings, and external engagements with partners and scientific societies.• Act as a trusted delegate for therapeutic area VP/SVP, contributing to senior leadership and governance decisions.• Drive thought leadership, participating in policy groups, workshops, and global panels on oncology drug development and regulatory innovation.• Co-founded and lead the AZ Dose Optimization Working Group, pioneering strategies for oncology drug dosing across small molecules, biologics, ADCs, and other modalities.• Cultivate and inspire high-performing, globally distributed teams through coaching, mentoring, and tailored development plans, ensuring talent growth and long-term success.• Spearhead resource planning and recruitment for Regulatory Affairs, building a strong talent pipeline and aligning individual goals with organizational objectives.

Education

• University of California, San Francisco

  Doctor of Pharmacy

• California State University-East Bay

  Bachelor of Science in Cell and Molecular Biology and Minor in Chemistry

• University of Kentucky Medical Center

  Hematology-Oncology Pharmacy Resident

  2012 — 2014