What you'll do

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.

Key responsibilities include:

• 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.
• 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 labelling negotiations.

What success looks like

In this role, you will:

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

Compensation and Benefits

AstraZeneca is committed to providing competitive, equitable and transparent compensation.

The annual base pay for this position ranges from $186,232 - $279,349 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Benefits offered included a qualified retirement program [401(k) plan]; paid vacation 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.

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