Regulatory Affairs Director - Oncology

About the role

Shape the future of oncology medicines and influence regulatory decisions that impact patients globally. As a Regulatory Affairs Director at AstraZeneca, you will define and execute US regulatory strategies to accelerate innovation and bring transformative oncology therapies to patients worldwide. This role involves leading complex regulatory initiatives across development, submission, approval, and lifecycle management while partnering with scientists, clinicians, and commercial teams in a global matrix environment.

Why AstraZeneca?

AstraZeneca follows the science and puts patients first. You will join a culture that values curiosity, courage, and collaboration, where talented individuals are empowered to challenge convention and shape the future of healthcare. The company invests in its people through career development, global mobility opportunities, leadership programs, and cutting-edge scientific innovation. AstraZeneca’s Oncology business continues to redefine cancer treatment, offering regulatory leaders the chance to influence some of the most exciting programs in the industry.

Responsibilities

• Develop and implement regional regulatory strategies supporting rapid approvals and competitive product labeling.
• Lead major regulatory submissions, including INDs, NDAs, and BLAs.
• Drive regulatory agency engagement strategies and lead health authority interactions.
• Lead cross-functional US Oncology Regulatory Strategy teams, including clinical development, CMC, labeling, and regional regulatory functions.
• Assess regulatory risks and develop mitigation strategies to support program success.
• Influence global product strategy through regulatory expertise and scientific insight.
• Lead preparation of regulatory strategy documents, briefing packages, and target labeling.
• Represent AstraZeneca in discussions with global health authorities and external stakeholders.

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 programs.
• Experience with regulatory submissions and agency interactions, including INDs, NDAs, and/or BLAs.
• Demonstrated ability to lead complex cross-functional initiatives and influence key stakeholders.
• Outstanding communication, strategic thinking, and problem-solving skills.
• Experience operating effectively in a global matrix environment.

Preferred Qualifications

• Oncology regulatory experience.
• Advanced degree (MS, PharmD, PhD, MD, or equivalent).
• Experience leading regulatory strategies through pivotal development milestones and health authority interactions.
• Prior involvement in regulatory approvals, response teams, and labeling negotiations.

What Success Looks Like

• Deliver critical regulatory milestones for Oncology that support program progression and approvals.
• Build productive relationships with health authorities and key internal stakeholders.
• Provide strategic leadership across complex, high-profile development programs.
• Influence decisions that drive patient access to innovative medicines in the US market.

Pay

The annual base pay for this position ranges from $186,232 to $279,349 USD. Base pay may vary depending on market location, job-related knowledge, skills, and experience. Eligible employees may also participate in a short-term incentive bonus opportunity, equity-based long-term incentive program (for salaried roles), retirement contribution (for hourly roles), and commission payments (for sales roles). Benefits include a qualified retirement program (401(k) plan), paid vacation and holidays, paid leaves, and health benefits such as medical, prescription drug, dental, and vision coverage.

Date Posted: 14-Aug-2026