US Regulatory Director - Oncology Strategy

AstraZeneca; Gaithersburg (MD); Sur place; USD 186 000 - 279 000; Plein temps

Résumé du poste

AstraZeneca seeks a Regulatory Affairs Director to shape US regulatory strategy for oncology therapies, accelerating innovation and patient access. You will lead regional regulatory initiatives across development, submission, approval and lifecycle management in a global matrix environment.

You will drive major submissions (INDs, NDAs, BLAs), engage health authorities, and guide cross-functional teams through complex programs with strategic insight and strong communication skills.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Significant regulatory affairs experience in pharma/biotech.
• Experience with regulatory strategies across development stages.
• Experience with INDs, NDAs and BLAs.
• Ability to lead cross-functional initiatives and influence stakeholders.
• Excellent communication and strategic thinking.
• Experience operating in a global matrix environment.

Responsabilités

• Develop regional regulatory strategies to support rapid approvals.
• Lead major regulatory submissions (INDs, NDAs, BLAs).
• Drive health authority engagement and interactions.
• Lead US Oncology Regulatory Strategy teams across functions.
• Assess regulatory risks and mitigation plans for programmes.
• Influence global product strategy with regulatory insight.
• Prepare regulatory strategy documents and briefing packages.
• Represent AstraZeneca in discussions with health authorities.

Connaissances

Strategic thinking

Leadership

Regulatory strategy

Cross-functional collaboration

Formation

Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related

Advanced degree (MS, PharmD, PhD, MD or equivalent)

Description du poste

AstraZeneca seeks a Regulatory Affairs Director to shape US regulatory strategy for oncology therapies, accelerating innovation and patient access. You will lead regional regulatory initiatives across development, submission, approval and lifecycle management in a global matrix environment.

You will drive major submissions (INDs, NDAs, BLAs), engage health authorities, and guide cross-functional teams through complex programs with strategic insight and strong communication skills.