Senior Director, Regulatory Affairs Management – Infectious Diseases

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

Accountabilities

• 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, and 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 activities, including overseeing team resources and headcount, guiding priorities and assignments as business needs evolve, ensuring regulatory fees and other departmental costs are accurately forecasted, monitored and managed to support delivery within approved budget targets, contributing to business cycle planning, and supporting organizational readiness
• Ensure accurate Infectious Disease Regulatory Affairs resource and cost projections are developed in collaboration with departmental leadership and functional partners for timely integration into enterprise-level processes and other purposes
• Serve as a key business partner to Regulatory Affairs leadership by driving cross-functional alignment, enabling effective governance and decision-making, and ensuring execution of key strategic and operational objectives
• Monitor evolving global and regional regulatory submission operational requirements, assess their implications for the Infectious Disease portfolio and advise stakeholders on strategic operational 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 across the Regulatory Affairs Management community
• Model AstraZeneca values and foster an inclusive, courageous and high-performing team that delivers effectively across functions, geographies and cultures

Minimum Qualifications

• 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
• 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

Desirable Qualifications

• 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 within regulatory operations, drug project delivery, or compliance in a global context
• Budget management experience and commercial acumen; experience 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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

We work in person an average of at least three days each week to strengthen connection, collaboration, bold thinking and pace, while maintaining flexibility based on individual and business needs.

Why AstraZeneca

In this role, you will help translate scientific innovation into medicines for patients while working with globally connected colleagues who combine scientific and regulatory expertise with a strong commitment to patients.

You will have the opportunity to shape the Regulatory Affairs Management function, develop talent and improve how regulatory work is planned and delivered. Our global community uses data, automation, knowledge sharing and continuous improvement to simplify work and accelerate high-quality outcomes.

The annual base pay for this position ranges from $218,058.40 - 327,087.60 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an \"at-will position\" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.