Global Senior Regulatory Affairs Director — Strategy

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 218,058 - 327,087; Full time

Benefits offered by this job

401(k) plan

Health benefits

Job summary

AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid approvals and advantageous labeling.

You will chair the Global Regulatory Sub-team with regional input, manage regulatory milestones, and mentor RAD/ARAD staff across regions.

The role offers comprehensive benefits and a pathway to influence oncology programs and interactions with Health Authorities.

Qualifications

• Bachelor’s degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• 10+ years experience in drug/biologic development processes and strategies for high profile, complex or novel development programs.
• Deep understanding of global regulatory science and integration with program strategy.
• Proven experience leading regulatory, cross-functional teams, and stakeholder management.
• Excellent oral, written, and presentation skills.

Responsibilities

• Lead the global regulatory strategy for a product/group of products of increasing complexity.
• Oversee the planning and construction of the global dossier and core prescribing information.
• Lead the Global Regulatory Sub-team (GRST) with regional perspectives and cross-functional input.
• Manage regulatory milestones including assessment of regulatory success and risk mitigation.
• Lead and mentor Regulatory Affairs Directors and staff across regions.

Skills

Strategic leadership

Global regulatory science

Regulatory affairs

Stakeholder management

Team leadership

Regulatory approvals

Education

Bachelor's degree in a scientific discipline

Job description

AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid approvals and advantageous labeling.

You will chair the Global Regulatory Sub-team with regional input, manage regulatory milestones, and mentor RAD/ARAD staff across regions.

The role offers comprehensive benefits and a pathway to influence oncology programs and interactions with Health Authorities.