Global Regulatory Strategy Director

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

Benefits offered by this job

Retirement plans

Paid time off

Health/dental/vision coverage

Job summary

AstraZeneca in Gaithersburg is seeking a Global Regulatory Affairs Director to provide strategic regulatory leadership across development, commercialization, and lifecycle management. You will apply global regulatory trends to shape strategies and influence authorities to improve outcomes.

The role requires leadership, strong project management, and a broad regulatory background, including health authority interactions, with a focus on collaboration across global teams and regions.

Qualifications

• Bachelor’s degree or higher in life sciences or related field.
• Advanced degree is a plus.
• 6 years of regulatory drug development experience.
• Broad regulatory affairs background including health authority interactions.
• Proven leadership and project management experience.

Responsibilities

• Provide strategic and operational regulatory leadership for development, commercialization and lifecycle management of assigned products.
• Apply knowledge of local and global regulatory trends to identify future requirements and strategies.
• Influence regulatory authorities through regular contacts to improve outcomes.
• Manage skill groups, develop talent, and allocate resources.
• Collaborate across global, regional, and local Regulatory Affairs interfaces for submissions and maintenance.

Skills

Regulatory leadership

Project management

Regulatory affairs knowledge

Leadership experience

Regulatory strategy

Education

Bachelor’s Degree in Life Science or related discipline

Advanced degree

Job description

AstraZeneca in Gaithersburg is seeking a Global Regulatory Affairs Director to provide strategic regulatory leadership across development, commercialization, and lifecycle management. You will apply global regulatory trends to shape strategies and influence authorities to improve outcomes.

The role requires leadership, strong project management, and a broad regulatory background, including health authority interactions, with a focus on collaboration across global teams and regions.