Executive Director, Regulatory Affairs Strategy Cell Therapy

Job Title: Executive Director Regulatory Affairs Strategy - Cell Therapy

Introduction to role:

• Are you ready to set the global regulatory direction for first-in-class cell therapies and turn science into approved medicines Do you see yourself steering complex programs to competitive labels and rapid global patient access
• This role leads the strategy for our most visible and complex cell therapy programs translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value.
• You will work across discovery through commercialization bringing clarity and pace to decision-making and ensuring our therapies reach patients with unmet needs.
• You will directly shape how we engage with health authorities define target product labeling and accelerate submissions across multiple indications and modalities.
• As a senior leader you will build capability coach regulatory talent and influence policy and guidance to sustain a competitive edge for our pipeline and portfolio.

Accountabilities:

Essential Skills/Experience:

• An advanced degree in a science-related field plus leadership experience (able to lead other leaders).
• Demonstrated extensive success in cell therapy regulatory strategy.
• Deep understanding of global regulatory science and integration with program franchise and portfolio strategy.
• Long-standing experience of overall drug/biologic development processes and strategies for high profile highly complex novel or first-in-class development programs.
• Experience with product development in the following therapeutic areas: oncology autoimmune rare diseases neurology.
• Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs.
• Proven experience leading regulatory and cross-functional teams influencing senior stakeholders and operating effectively in complex matrix environments.
• Ability to think strategically and critically at enterprise level and evaluate risks to regulatory and business activities.
• Previous significant experience in leading Health Authority interaction in major markets. Excellent oral written and presentation skills.
• Strong organizational skills. Ability to work in a fast-paced environment in a hands-on fashion.
• Flexible and proactive with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
• Experience working on due diligence activities and in a business alliance environment.
• Experience in leading and growing people through line management coaching or mentorship. Contribution to non-project business initiatives at a portfolio franchise or enterprise level. Experience contributing to external policy regulatory science or industry advocacy initiatives.

Desirable Skills/Experience:

• Experience with product development in oncology autoimmune rare diseases and neurology across multiple indications and modalities.
• Experience working on due diligence activities and in a business alliance environment.
• Experience contributing to external policy regulatory science or industry advocacy initiatives.

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. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 transformative science meets decisive execution. You will help convert cutting-edge cell therapy innovation into globally approved medicines for patients with unmet needs working in a connected inclusive environment that values kindness alongside ambition.

We bring diverse experts together to spark bold ideas apply modern regulatory approaches and harness data and technology to shorten development cycles. With a rich pipeline and empowered teams your leadership will shape labels accelerate access and create lasting impact for patients worldwide.

Call to Action:

Step into a role where your regulatory leadership defines the path from discovery to approvaltake the lead and shape the future of cell therapy today!

Date Posted

Closing Date