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AstraZeneca

Executive Director, Regulatory Science & Strategy – Oncology

AstraZeneca

Executive Regulatory Science Director providing global strategic regulatory expertise in Oncology. Mentoring regulatory leads and aligning innovative regulatory strategies across product development.

Posted 6/3/2026full-timeGaithersburg • Maryland, Massachusetts • 🇺🇸 United StatesLead💰 $267,000 - $401,000 per yearWebsite

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Hard Skills
regulatory expertiseregulatory strategiesdrug developmentoncologyHematologyglobal regulatory strategyhealth authority interactionssubmission excellence framework
Soft Skills
coachingmentoringstrategic thinkingcritical evaluationteam leadership
Certifications & Qualifications
Bachelor’s degree in life sciences
Industry Keywords
global regulatory affairsdisease area policiesregulatory product developmentregulatory approval

About the role

Key responsibilities & impact
  • Provide global strategic regulatory expertise and oversight
  • Coach and mentor regional and global regulatory leads
  • Partner with Regulatory Affairs Directors aligning innovative regulatory strategies
  • Lead resource planning and recruitment of staff
  • Provide critical review and input on regulatory strategies
  • Represent Global Regulatory Affairs in senior level interactions
  • Collaborate with regional policy and intelligence groups
  • Define and drive disease area global regulatory policies and priorities
  • Ensure submission excellence framework is timely and consistently applied

Requirements

What you’ll need
  • Bachelor’s degree in life sciences and/or science related field
  • More than 10 years drug development experience
  • Oncology therapy area knowledge/experience, ideally expertise with Hematology assets
  • Deep knowledge of global regulatory strategy experience with all phases of oncology drug development
  • Significant experience in leading major health Authority interactions
  • Proven experience of growing high performance teams
  • Ability to think strategically and critically to evaluate risks to regulatory product development and approval
  • Ability to travel domestically and internationally

Benefits

Comp & perks
  • Competitive salary and benefits package
  • Short-term incentive bonus opportunity
  • Eligibility to participate in the equity-based long-term incentive program
  • Retirement contribution
  • Qualified retirement program [401(k) plan]
  • Paid vacation and holidays
  • Paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage