Head of Regulatory Affairs – Cell Therapy Immunology
Location: Boston, Massachusetts, USA
Job ID: R-202496
Date Posted: 04 Nov 2025
Closing Date: 18 Nov 2025
About AstraZeneca
AstraZeneca is redefining treatment for life-threatening immune-mediated diseases through next-generation cell therapies. The company is expanding internal capabilities across discovery, development, and delivery of cellular therapies. As part of the Regulatory Affairs organization, the Head of Regulatory Affairs plays a critical leadership role in advancing these transformational therapies from research to commercialization.
Role Overview
The Head of Regulatory Affairs, Immunology Cell Therapy provides global regulatory leadership and strategic direction across early development, late-stage programs, and post-marketing activities for cell therapy products in immune-mediated diseases.
This is a senior, high-influence role requiring scientific depth, strategic thinking, strong negotiation skills, and the ability to lead in ambiguity while supporting a growing organization.
Key Responsibilities
1. Strategic Leadership & Oversight
Lead, mentor, and partner with Regulatory Affairs Directors (RADs) and Senior RADs to develop regulatory strategies aligned with disease area and portfolio objectives.
Ensure strategies are negotiated with global Health Authorities (FDA, EMA, CDE, etc.) to secure rapid approvals and competitive labeling.
2. Regulatory Expertise & Influence
Provide expert regulatory guidance across early development, late-stage programs, and established products.
Drive regulatory components of development specific to cell and gene therapies, including:
Novel endpoints and biomarkers
Innovative study designs
Digital applications
3. Senior Committee Representation
Represent Regulatory Affairs in senior governance bodies such as:
Development Review Committee (DRC/eDRC)
Early Development Review Board
Global Medical Affairs (GMA) Review Committees
4. Policy, Intelligence & Environment Shaping
Collaborate with regional policy and intelligence groups to assess emerging science, regulatory changes, and competitive landscapes.
Define and drive global regulatory priorities, policies, and long-term strategies within the therapeutic area.
5. Organizational Leadership
Ensure adequate regulatory resources and capability to support the portfolio.
Partner with cross-functional teams to provide regulatory insight during key investment and milestone decisions.
Required Qualifications
Education
Bachelor’s degree in life sciences or related scientific field (or equivalent experience).
Experience
10+ years of drug development experience.
Strong knowledge of immunology therapeutic area and cell therapy regulatory science.
Proven experience in global regulatory strategy, submissions, and progression through registration.
Significant experience leading major Health Authority interactions.
Broad experience across pharmaceutical/medical industry in multiple regulatory areas (e.g., global, EU, international, marketing company, or Health Authority).
Experience managing teams in a matrixed environment.
Preferred Qualifications
Advanced scientific degree (MSc, PhD, PharmD, MD).
Deep expertise in immune-mediated diseases and cell therapy regulation.
Work Expectations
Position is Boston-based.
Hybrid model: minimum 3 days/week in office, maintaining flexibility while promoting collaboration and innovation.
Compensation & Benefits
Annual Base Salary (US Range): $266,596.80 – $399,895.20
(Actual salary depends on experience, skills, and market factors)
Short-term incentive bonus opportunity
Long-term equity-based incentive program (for salaried roles)
Retirement benefits (401k)
Paid vacation, holidays, and leaves
Health insurance: medical, dental, prescription, and vision
Employment is at-will, with salary adjustments possible based on performance and market conditions
Diversity & Inclusion
AstraZeneca is committed to building an inclusive, diverse team representing a wide range of backgrounds and perspectives. All qualified candidates are encouraged to apply regardless of protected characteristics.
Accommodation is available for applicants with disabilities.
Additional Information
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