Global Regulatory Affairs Director – Infectious Diseases

AstraZeneca plc; Gaithersburg (MD); Hybrid; USD 218,000 - 327,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits

Job summary

AstraZeneca plc is seeking a Senior Regulatory Affairs Director to oversee global regulatory strategy for Infectious Diseases programs. This role leads cross-functional teams, guides regulatory submissions, and interacts with health authorities to secure timely approvals.

Flexible hybrid work is available with on-site collaboration. The SRAD drives strategic decision-making, manages complex global dossiers, and collaborates with GPTs to align regulatory plans with development milestones and

Qualifications

• Master’s degree in a science-related field or equivalent experience.
• 10+ years in regulatory drug development with global approvals.
• Infectious Diseases experience preferred.
• Leading major Health Authority interactions (FDA etc.).
• Demonstrated leadership and program management in complex programs.

Responsibilities

• Lead or deputise for TA VP/Regional VP in senior-level interactions.
• Develop and implement regulatory strategies to achieve rapid approvals.
• Lead planning of global dossiers and core prescribing information.
• Conduct regulatory risk planning and mitigation.
• Serve as Global Regulatory Affairs representative on Product Development Teams.
• Ensure regional regulatory needs are incorporated into Global Strategy.
• Deliver regulatory milestones and manage risk mitigation measures.
• Collaborate with marketing and regional staff to shape authority views.
• Oversee regulatory staff on complex projects to meet objectives.
• Represent regulatory discussions at health authority meetings with clear documentation.
• Develop and update of Regulatory Strategy Document for complex projects.

Skills

Regulatory leadership

Strategic thinking

Program management

Cross-functional collaboration

Global health authority interactions

Education

Master’s degree

Advanced degree preferred

Job description

AstraZeneca plc is seeking a Senior Regulatory Affairs Director to oversee global regulatory strategy for Infectious Diseases programs. This role leads cross-functional teams, guides regulatory submissions, and interacts with health authorities to secure timely approvals.

Flexible hybrid work is available with on-site collaboration. The SRAD drives strategic decision-making, manages complex global dossiers, and collaborates with GPTs to align regulatory plans with development milestones and