Shaily Arora

Experience

1. Executive Director, Oncology Regulatory Strategy

   AstraZeneca

   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

• California State University-East Bay

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

• University of California, San Francisco

  Doctor of Pharmacy

• University of Kentucky Medical Center

  Hematology-Oncology Pharmacy Resident

  2012 — 2014