Senior Director, Regulatory Affairs Management – Infectious Diseases

AstraZeneca • Gaithersburg, MD

5d • $218,058 - $327,088 • Onsite

About The Position

The Senior Director, Regulatory Affairs Management for the Infectious Disease Unit leads and develops the Regulatory Affairs Management team and sets the strategic direction for regulatory delivery across Infectious Disease portfolios. As a member of the ID Regulatory Affairs Leadership Team, this role partners with Regulatory Affairs colleagues globally to ensure high-quality, compliant submission delivery, strengthen organizational capability, and advance continuous improvement.

The role oversees regulatory project management and operational delivery for development-stage and approved products across the global portfolio. It leads strategic planning, operational coordination, resource and headcount management, budget forecasting, and organizational readiness. The Senior Director also advises stakeholders on evolving regulatory operational requirements and leads improvements to global regulatory policies, processes, and capabilities.

The position is based on in-person collaboration an average of at least three days each week, with flexibility based on individual and business needs. It offers an opportunity to shape the Regulatory Affairs Management function, develop talent, and improve regulatory planning and delivery in support of medicines for patients.

Requirements

• Bachelor’s degree in a science-related field.
• At least 10 years of regulatory affairs experience in the biopharmaceutical industry, a related sector, or a health authority, including leadership of regulatory or cross-functional teams.
• Ability to apply global and regional regulatory requirements to plan and deliver major submissions, manage compliance obligations, and support products across the lifecycle.
• Success leading and developing regulatory professionals through coaching, performance management, and succession planning.
• Strong project, portfolio, and resource management skills, including setting priorities and delivering through global, cross-functional teams.
• Strong strategic judgment, risk assessment, and decision-making skills, with ability to influence senior internal stakeholders in complex or ambiguous situations.
• 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, including influencing key decisions and building partnerships across local, global, and virtual teams.
• Success leading organizational change, process improvement, and adoption of new ways of working.

Nice To Haves

• Advanced degree or further professional qualifications in a relevant discipline.
• Experience with infectious disease products, including vaccines, antivirals, antibacterials, or monoclonal antibodies.
• Knowledge of AstraZeneca’s business, processes, and Regulatory Operating Model.
• Experience across multiple therapeutic areas or in regulatory operations, drug project delivery, or compliance in a global context.
• Budget management experience and commercial acumen, including developing business cases and tracking benefits for larger programmes.
• Facilitation skills and experience leading cross-functional workshops or governance forums.
• Experience anticipating emerging regulatory practices and translating them into strategic opportunities, risk mitigations, or improved ways of working for pharmaceutical and biological products.

Responsibilities

• Oversee regulatory project management and operational delivery for development-stage and approved products across the global Infectious Disease portfolio.
• Lead and develop the Infectious Disease Regulatory Affairs Management team through direct and indirect people leadership, coaching, performance management, succession planning, and recruitment; represent the team across the broader Regulatory Affairs organization.
• Define and implement regulatory submission models that improve efficiency, quality, and value, and secure organizational support for their adoption.
• Ensure regulatory milestones, submissions, and compliance activities are planned, forecast, reported, and delivered to required quality standards and timelines.
• Build effective internal and external partnerships and represent AstraZeneca, as appropriate, with health authorities, trade associations, and other regulatory organizations.
• Represent Infectious Disease Regulatory Affairs in driving cross-functional alignment, effective decision-making, and execution of strategic and operational objectives.
• Lead strategic planning and operational coordination, including overseeing team resources and headcount, guiding priorities and assignments, managing regulatory fees and departmental costs against approved budget targets, contributing to business cycle planning, and supporting organizational readiness.
• Develop accurate resource and cost projections with departmental leadership and functional partners for integration into enterprise-level processes and other purposes.
• Serve as a key business partner to Regulatory Affairs leadership by driving cross-functional alignment, enabling governance and decision-making, and ensuring execution of strategic and operational objectives.
• Monitor evolving global and regional regulatory submission operational requirements, assess implications for the Infectious Disease portfolio, and advise stakeholders on opportunities, risks, and required actions.
• Lead the development and improvement of global regulatory policies, processes, and capabilities, promoting knowledge sharing and consistent, efficient ways of working.
• Model AstraZeneca values and foster an inclusive, courageous, high-performing team that delivers across functions, geographies, and cultures.

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior