Senior Director, Regulatory Affairs Strategy Cell Therapy

Job Title: Senior Director Regulatory Affairs Strategy - Cell Therapy

Available locations:

• Gaithersburg MD
• Boston MA
• South San Francisco CA
• Santa Monica CA

Introduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients

This role leads high-impact programs across cancer immune-mediated and rare diseases guiding them from current stage through licensure with clear competitive pathways to approval and labeling.

You will shape strategy for complex visible programs bringing clarity pace and rigor that accelerate access for patients.

You will report to the Executive Director Cell Therapy Regulatory Affairs and act as a franchise global regulatory lead for programs with multiple indications with the opportunity to serve in a dual capacity as a regional lead based on your expertise. Working across discovery through commercialization you will partner closely with Global Product Teams to align science evidence and policy while coaching a Global Regulatory Strategy Team to deliver at the highest level.

Could you be the strategic voice that anticipates risk seizes expedited opportunities and influences the dialogue with global health authorities

Accountabilities:

Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell therapy program from current stage through BLA submission ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient market and business needs. -

Franchise and Regional Responsibility: Serve as global regulatory lead for complex multi-indication programs and where relevant take on regional leadership to integrate region-specific strategy and execution.

Health Authority Strategy and Engagement: Lead strategy for agency meetings information requests and expedited pathway designations; drive robust preparation that secures clear outcomes and de-risks pivotal milestones.

Dossier and Labeling Excellence: Direct the planning and construction of the global dossier and core prescribing information; own target product labeling strategy and negotiation readiness.

Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams shaping development and commercialization plans contributing to governance presentations and aligning regulatory objectives with clinical CMC safety and commercial strategies.

Evidence and Decision-Making: Continuously assess emerging data against program aspirations; present risks trade-offs and mitigations to senior leadership to enable decisive data-driven choices.

Delivery and Milestone Management: Oversee all regulatory deliverables and milestones including probability-of-success assessments and contingency planning to protect timelines and value.

Team Leadership and Talent Development: Lead a Global Regulatory Strategy Team for specific indications/programs; coach mentor and as applicable line-manage team members to build capability and performance.

External Influence and Partnerships: Build strong relationships with regulatory stakeholders; partner with country and regional regulatory teams to shape developing views and guidance.

Innovation and Tools: Lead and promote the development of novel regulatory tools and technology and contribute to non-project initiatives that advance how we work and the impact we deliver.

Marketed Product Stewardship: Maintain accountability for product maintenance and compliance activities associated with marketed brands ensuring continued benefit to patients and compliance with evolving requirements.

Essential Skills/Experience:

• An advanced degree in a science related field and seven to ten years of experience and/or appropriate knowledge/experience.
• Demonstrated success in cell therapy regulatory strategy.
• Deep understanding of global regulatory science and integration with program strategy.
• Long standing experience of overall drug/biologic development processes and strategies for high profile complex or novel development programs.
• Experience with product development in the following therapeutic areas: oncology autoimmune rare diseases neurology.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Proven experience leading regulatory and cross-functional teams and stakeholder management.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Previous experience in leading Health Authority interactions 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.
• Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations

Desirable Skills/Experience:

• Experience with FDA advisory committee and/or EMA oral explanation. - Experience working on due diligence activities and in a business alliance environment.
• Experience in leading and growing people through coaching or mentorship.
• Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level).

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -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 your regulatory leadership turns cutting-edge cell therapy science into treatments that change livesfast.

You will work in a collaborative empowered environment that blends scientific ambition with practical execution where unexpected teams come together to challenge assumptions share knowledge across borders and adopt new technology to shorten development cycles. We value kindness alongside ambition give you the autonomy to lead and the support to grow and connect your individual impact directly to patients who are waiting.

Pay Transparency:

The annual base pay for this position ranges from $218058 - $327087 USD Annual. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and 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: If you are ready to lead global regulatory strategy for transformative cell therapies and leave a clear lasting mark on patient outcomes we invite you to step forward and start the conversation today.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.