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About the Role

This role supports high-impact programs across cancer, immune-mediated and rare diseases, guiding regulatory delivery and project management for projects spanning early development through licensure. You will work hand in hand with the global regulatory strategy teams in a dynamic environment, to advance complex cell therapy programs. By being responsible for project management and process activities, you will contribute to effecting high stake's engagement with global regulatory authorities.

Responsibilities

Leading the Process Management Team
Leading a team of process management professionals, providing guidance and support, ensuring team's success.
Allocate resources against “book of work” for Regulatory Process management team, aligning personnel with business priorities and individual development goals. Ensure cost effective and flexible resource management
Provide line management for direct reports, agree yearly objectives and give regular status updates.
Recruitment, development, retention, and talent management of staff, including succession planning
Ensure all work is performed in accordance with established procedures and internal and external requirements.
Together with the Process Leads ensure process management activities are strategically aligned across the Regulatory area
Collaborating with internal stakeholders to understand their requirements
Finding opportunities for process improvement, automation, or innovation within regulatory processes
Drive efficiency and quality in Process Management work
Participate in AZ R&D activities to influence development Process Management Standards, Guidance and tools
Drive a culture of continuous improvement, including adopting “Lean” type process improvement methodologies.
Promote identification of underlying barriers to success
Review and agrees high-level demand and supply and make recommendation for strategic changes, if needed.
Partner with stakeholders within RTE, including Digital Strategy and Governance leaders to ensure process support for future (transformation) processes.
Responsible for coordinating and managing the entire lifecycle of the nominated area, including Regulatory processes and procedural documents. This role also ensures adherence to industry regulations and AstraZeneca's Global and Local Policies.
Owns and is accountable for the long term stewardship of their nominated area and for successful delivery of the business benefits.

Requirements

Experience and understanding of the research and drug development life cycle and of the needs and ways of working of Regulatory Affairs
3 plus years of experience in regulatory affairs
Bachelors degree in Science or a related discipline
Strong leadership skills, including a demonstrated ability to manage stakeholders and influence the broader organization.
Passion for people development
Successful leadership and project management experience
Consistent track record to develop others to meet personal aspirations and business needs
Proven ability to drive and implement change and improvement projects
Experience of working in a global organisation – across countries, cultures, and time zones.
Line manager experience
Results Focused – ability to overcome obstacles and achieve key outcomes
Cultural Awareness – able to work successfully in a multi-cultural environment
Analytical Thinking - logically breaking situations or issues down into their essential elements; carrying out diagnosis and developing solutions.
Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
Builds effective partnerships – finds opportunities and takes actions to form effective relationships within team and with other areas
Experience as Business Process Owner (or BPAL) working with Procedural Document and BPM tools
Knowledge of AZ business and processes.
In-depth regulatory knowledge and understanding of key regulatory activities and processes, Submission Excellence and Regulatory Operating Model
Facilitation skills

Skills

Process Management
Project Management
Stakeholder Management
People Development
Change Management
Continuous Improvement
Lean Methodologies
Analytical Thinking
Relationship Building
Facilitation Skills

Location

Gaithersburg
Boston
Santa Monica
South San Francisco

Work Type

Hybrid
3 days in office

Experience Level

3 plus years of experience in regulatory affairs
Line manager experience

Education Level

Bachelors degree in Science or a related discipline

Salary/Compensations

$186,232.80 - $279,349.20 USD Annual

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program
Retirement contribution
Commission payment eligibility
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

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.
Here, regulatory leaders help transform pioneering science into therapies that reach patients faster—by driving innovative approaches, smart risk-taking, and disciplined execution. You will work across a rich pipeline with colleagues who value curiosity and kindness alongside ambition, bringing unexpected teams together to unlock knowledge and sharpen strategy.
Our globally connected community blends cutting-edge technology with deep disease expertise, embraces data and automation to reduce cycle times, and thrives on collaboration that turns complex challenges into concrete outcomes for patients. Your ideas will be heard, your growth supported, and your impact visible in every milestone we achieve.

Equal Opportunity

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.