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Regulatory Affairs Director - OncologyAstraZeneca · US - Gaithersburg - MD
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AstraZeneca

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Regulatory Affairs Director - Oncology

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🗓️ Posted 2026-08-14 US - Gaithersburg - MD Full-time Hybrid General
💰 Salary Not shared 📊 Market 14,166 GBP–20,833 GBP/mo

About the Company

Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally At AstraZeneca, we are driven by our commitment to advancing science and delivering life-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing US regulatory strategies that accelerate innovation and bring transformative oncology therapies to patients worldwide. This is an opportunity to lead complex regulatory initiatives across development, submission, approval and lifecycle management activities while partnering with leading scientists, clinicians and commercial teams across a global matrix environment. Why AstraZeneca At AstraZeneca, we follow the science and put patients first.

Responsibilities

  • ● talented individuals are empowered to challenge convention and shape the future of healthcare. We invest in our people through meaningful career development, global mobility opportunities, leadership programmes and cutting-edge scientific innovation.
  • ● Our Oncology business continues to redefine what is possible in cancer treatment, creating opportunities for regulatory leaders to influence some of the most exciting programmes in the industry.
  • ● As Regulatory Affairs Director, you will provide strategic and operational regulatory leadership for assigned development programmes and marketed products. You will serve as a Regional US Regulatory Lead for the Oncology programme.
  • ● Developing and implementing regional regulatory strategies that support rapid approvals and competitive product labelling.
  • ● Leading major regulatory submissions, including INDs, NDAs and BLAs.
  • ● Driving regulatory agency engagement strategies and leading health authority interactions.
  • ● Leading cross-functional US Oncology Regulatory Strategy teams, clinical development, CMC, labelling and regional regulatory functions.
  • ● Assessing regulatory risks and developing mitigation strategies to support programme success.
  • ● Influencing global product strategy through regulatory expertise and scientific insight.
  • ● Leading preparation of regulatory strategy documents, briefing packages and target labelling.
  • ● Representing AstraZeneca in discussions with global health authorities and external stakeholders. Essential qualifications
  • ● Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline
  • ● Significant experience within Regulatory Affairs, Regulatory Strategy and/or drug development in the pharmaceutical or biotechnology industry.
  • ● Strong experience supporting regulatory strategies across early and late-stage development programmes.
  • ● Demonstrated ability to lead complex cross-functional initiatives and influence key stakeholders.
  • ● Outstanding communication, strategic thinking and problem-solving skills.
  • ● Oncology regulatory experience.
  • ● Advanced degree (MS, PharmD, PhD, MD or equivalent).
  • ● Prior involvement in regulatory approvals, response teams and labelling negotiations. What success looks like
  • ● In this role, you will:

Benefits

  • ● ation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
  • ● Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
  • ● Inclusion & Diversity
  • ● AstraZeneca is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome applications from all qualified candidates and make employment decisions without regard to legally protected characteristics.
  • ● Ready to make an impact
  • ● Join AstraZeneca and help deliver the next generation of medicines that transform the lives of patients around the world.
  • ● Apply today to become part of a team where science, innovation and collaboration drive meaningful change.
  • ● Date Posted 14-Aug-2026
  • ● Closing Date 27-Aug-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.