Senior Director, Infectious Disease Regulatory Leadership

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

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation

Job summary

AstraZeneca plc is seeking an experienced regulatory leader for its Infectious Disease portfolio. You will manage global regulatory project delivery across development-stage and approved products, and lead the Regulatory Affairs Management team with coaching and succession planning.

You will design submission models, forecast budgets and resources, and partner with health authorities to ensure timely, high-quality submissions while aligning with enterprise goals and regulatory strategy.

Qualifications

• Bachelor’s degree in a science related field.
• 10+ years of regulatory affairs experience with leadership of regulatory or cross-functional teams.
• Proven ability to apply global and regional regulatory requirements to plan and deliver major submissions, manage compliance obligations and support products across the lifecycle.
• Demonstrated success leading and developing regulatory professionals through coaching, performance management and succession planning.
• Strong project, portfolio and resource management skills, with the ability to set priorities and deliver through global, cross-functional teams.
• Strong strategic judgment, risk assessment and decision-making skills, with the ability to influence senior internal stakeholders in complex or ambiguous situations.
• Demonstrated experience leading major regulatory submissions, coordinating cross-functional contributors and resolving delivery risks to achieve required quality standards and timelines.
• Experience translating regulatory requirements and regional practices into practical submission plans, delivery decisions and project-management approaches.
• Excellent written, verbal and interpersonal communication skills with experience influencing key decisions and building effective partnerships across local, global and virtual teams.
• Demonstrated success leading organizational change, process improvement and adoption of new ways of working.

Responsibilities

• Oversee regulatory project management for development-stage and approved products.
• Lead and develop the Infectious Disease Regulatory Affairs Management team through coaching, performance management and recruitment.
• Define and implement regulatory submission models that improve efficiency, quality and value.
• Ensure regulatory milestones, submissions and compliance activities are planned, forecast, reported and delivered on time.
• Build partnerships with health authorities and regulatory organizations.
• Represent Infectious Disease Regulatory Affairs in cross-functional alignment and decision making.
• Lead strategic planning and coordinate resources, headcount and budgets within approved targets.
• Ensure cost projections are integrated into enterprise processes for timely budgeting.

Skills

Regulatory leadership

People management

Strategic planning

Risk assessment

Cross-functional collaboration

Project management

Regulatory submissions

Budget management

Education

Bachelor's degree in science

Advanced degree

Job description

AstraZeneca plc is seeking an experienced regulatory leader for its Infectious Disease portfolio. You will manage global regulatory project delivery across development-stage and approved products, and lead the Regulatory Affairs Management team with coaching and succession planning.

You will design submission models, forecast budgets and resources, and partner with health authorities to ensure timely, high-quality submissions while aligning with enterprise goals and regulatory strategy.