Director, US Oncology Regulatory Strategy & Submissions

AstraZeneca; Gaithersburg (MD); On-site; USD 186,000 - 279,000; Full time

Job summary

AstraZeneca is seeking a Regulatory Affairs Director to shape US regulatory strategies for oncology programmes, partnering with scientists, clinicians, and commercial teams. You will lead regulatory submissions, drive agency engagement, and steer cross-functional teams in a global matrix environment.

The role demands leadership in complex programmes, strategic thinking, and the ability to influence decision-making to accelerate patient access to innovative medicines in the US market.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related field.
• Significant experience in Regulatory Affairs, Regulatory Strategy, and/or drug development.
• Experience with regulatory submissions (INDs, NDAs, BLAs) and agency interactions.
• Ability to lead cross-functional initiatives and influence stakeholders.
• Experience operating in a global matrix environment and strong communication.

Responsibilities

• Develop regional regulatory strategies to support rapid approvals and labeling.
• Lead major regulatory submissions (INDs, NDAs, BLAs).
• Drive health authority engagement strategies.
• Lead US Oncology Regulatory Strategy teams across clinical development, CMC, labeling.
• Assess regulatory risks and mitigation strategies.
• Influence global product strategy through regulatory expertise.
• Prepare regulatory strategy documents and briefing packages.
• Represent AstraZeneca in discussions with health authorities.

Skills

Regulatory Strategy

Cross-functional Leadership

Regulatory Submissions

Drug Development

INDs/NDAs/BLAs

Global Matrix Collaboration

Communication Skills

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Job description

AstraZeneca is seeking a Regulatory Affairs Director to shape US regulatory strategies for oncology programmes, partnering with scientists, clinicians, and commercial teams. You will lead regulatory submissions, drive agency engagement, and steer cross-functional teams in a global matrix environment.

The role demands leadership in complex programmes, strategic thinking, and the ability to influence decision-making to accelerate patient access to innovative medicines in the US market.