Regulatory Affairs Director - Oncology

AstraZeneca • Gaithersburg, MD

1d

About The Position

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. 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. 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Provide strategic and operational regulatory leadership for assigned development programmes and marketed products.
• Serve as a Regional US Regulatory Lead for the Oncology programme.
• Develop and implement regional regulatory strategies that support rapid approvals and competitive product labelling.
• 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, clinical development, CMC, labelling and regional regulatory functions.
• Assess regulatory risks and develop mitigation strategies to support programme success.
• Influence global product strategy through regulatory expertise and scientific insight.
• Lead preparation of regulatory strategy documents, briefing packages and target labelling.
• Represent AstraZeneca in discussions with global health authorities and external stakeholders.
• 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.

Benefits

• Competitive, equitable and transparent compensation.
• Annual base pay ranges from $ 186,232 - $279,349 USD Annual.
• Overtime pay when working qualifying overtime hours (for hourly and salaried non-exempt employees).
• Short-term incentive bonus opportunity.
• Eligibility to participate in our equity-based long-term incentive program (salaried roles).
• Retirement contribution (hourly roles).
• Commission payment eligibility (sales roles).
• Qualified retirement program [401(k) plan].
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Director