Director, Regulatory Affairs Strategy - Cell Therapy

AstraZeneca; Gaithersburg (MD); On-site; USD 186,000 - 279,000; Full time

Job summary

AstraZeneca is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to shape global regulatory paths and submissions across oncology, immune-mediated and rare diseases. You will partner with senior leaders and cross-functional teams to drive expedited designations, health authority interactions, and timely approvals while ensuring patient value remains central.

You will guide complex programs from pivotal data through approval, maintaining rigorous labeling and governance, and

Qualifications

• Bachelor's degree in a science-related field is required.
• Minimum 5+ years of regulatory experience with a focus on cell therapy.
• Experience leading regulatory strategy and cross-functional teams.

Responsibilities

• Contribute to and implement the global regulatory strategy for CGT programs.
• Lead regulatory activities for products or programs and coordinate with regional leads.
• Define efficient approval paths and align labeling with product characteristics.
• Drive Health Authority engagements, responses, and major submissions.
• Assess data, communicate risks, and inform senior management decisions.
• Support milestone delivery and governance for regulatory milestones.
• Lead preparation of regulatory strategy documents and labeling materials.
• Collaborate across Global Product Team and Global Regulatory Strategy Team.
• Improve regulatory processes and share knowledge across locations.

Skills

Regulatory strategy

Cell therapy

Regulatory leadership

Global regulatory

Stakeholder management

Health Authority

Education

Bachelor's degree in science

Job description

Job Title

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 steer global regulatory strategy for cell therapies that redefine standards of care for patients?

In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases—translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.

You will join a high-performing, cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and global teams, you will lead strategy across key milestones—from expedited designations and Health Authority interactions through major submissions and post-approval maintenance—helping the business deliver transformative therapies at pace and with rigor.

Can you see yourself guiding a complex program from pivotal data through approval and beyond while keeping patient value and global needs front and center?

Accountabilities

• Global Regulatory Strategy: Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed.
• Program Leadership: Serve as regulatory lead for a product, indication, or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead.
• Approval Path and Labeling: Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to product characteristics and business, market, and patient needs; contribute to governance presentations.
• Health Authority Engagements: Drive strategy and execution for Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission.
• Data-Driven Decision-Making: Maintain strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management.
• Milestone Delivery: Support delivery of all project-related regulatory milestones, including probability-of-success assessments and mitigation strategies.
• Core Documents and Labeling: Lead preparation of regulatory strategy documents and target product labeling; support planning and assembly of the global dossier and core prescribing information with the respective teams.
• Cross-Functional Collaboration: Operate as a core member of the Global Product Team and Global Regulatory Strategy Team, demonstrating strong strategic, communication, and collaboration skills to advance development objectives.
• Process Excellence: Participate in non-project initiatives to enhance regulatory processes, tools, and practices; foster knowledge sharing across locations and therapy areas.
• Country and Regional Alignment: Partner with country organizations and regional regulatory colleagues to align on evolving views, local considerations, and regulatory guidance.
• Team Development: Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities.

Essential Skills/Experience

• Bachelor's degree in a science related field
• 5+ years of regulatory experience with a strong preference on cell therapy.
• 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.
• 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.

Desirable Skills/Experience

• Advanced degree in science related field (MSc. PhD, MD)
• Experience in cell therapy regulatory strategy or related regulatory activities.
• Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
• Experience supporting a global regulatory approval or major submission activity.
• Experience with FDA advisory committee or EMA oral explanation preparation.
• Experience working on due diligence activities or in a business alliance environment.
• Experience mentoring colleagues or contributing to team development. - Contribution to non-project business initiatives or cross-functional improvement activities.

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 - $279,349 USD 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.

• 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
• 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)

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.