Group Director Regulatory Process- Cell Therapy

Location: Gaithersburg, Boston, Santa Monica, South San Francisco

Hybrid: 3 days in office

Are you ready to contribute to setting the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients?

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.

You will report to the Executive Director, Cell Therapy Regulatory Affairs.

About the role:

As the Group Director Regulatory Process, you will be leading a team of skilled & specialist Process Management professionals who will manage, deliver and actively drive continuous improvement of Regulatory Processes and Procedural documents. You will be closely working with Process Leads and other internal stakeholders to improve ways of working and optimal resource utilization to deliver better experiences for our customer groups.

You will lead and conduct all Line Manager accountabilities, for a team that is comprised of Associate Directors and Managers, Regulatory Processes. Drive Skills development by sharing knowledge and mentoring of team. Define and deliver cycle of annual objectives, hiring, training, coaching, and career development of staff.

You will drive sub-departmental Leadership meetings and people related processes (Capacity Planning, Talent Mgt, RDP etc.). Manage and optimize relationships with key customer groups within regulatory and relevant other internal interfaces (e.g. R&D QA, other process-related groups).

You will participate in the department’s initiatives focusing on process development and improvement, including the optimal use of technology tools designed to improve efficiency. Depending on experience, may be accountable for Process Strategy for a sub-process area and/or cross-process initiatives requiring project management and leadership (e.g Integration of acquired company procedures).

Typical Accountabilities:

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.

Process Lead:

• 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.

Education, Qualifications, Skills and Experience:

Essential:

• 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

Desirable

• 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

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.

That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible.

We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca: 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.

Pay transparency

The annual base pay for this position ranges from $186,232.80 - $279,349.20 USD Annual. 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 salary (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.

Call to Action: Step into a role where your regulatory leadership accelerates life-changing therapies—seize this opportunity to shape strategy, deliver approvals, and grow your influence today.

#Li-Hybrid

Date Posted

27-Jul-2026

Closing Date

13-Aug-2026

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.