Regulatory Affairs Director - Oncology
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.
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
- 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.
Benefits
- Meaningful career development
- Global mobility opportunities
- Leadership programmes
- Cutting-edge scientific innovation
- Qualified retirement program [401(k) plan]
- Paid vacation and holidays
- Paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Director
