AstraZeneca · 18 hours ago
Head of Regulatory Affairs, Cell Therapy Immunology
Boston, MA
Full-time
Hybrid
Director/Executive
$267K/yr - $400K/yr
10+ years expAstraZeneca is utilizing cell therapy to transform the treatment of serious immune-mediated diseases. The Head of Regulatory Affairs for Immunology Cell Therapy will provide strategic regulatory expertise and oversight to support product development and commercialization, ensuring alignment with health authorities and business needs.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Provide oversight, partner with, and mentor RADs and SrRADs to produce strategies for a product/group of products in the Immunology Cell Therapy TA that are consistent with the disease area and portfolio strategy. The strategies should be crafted and negotiated with global health authorities (e.g FDA, EMA, CDE) to deliver a rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business and patients
Leads discussions in both internal and external forums, providing expertise in regulatory knowledge of disease area
Influences and drives regulatory strategies and recommendations at all stages of development, in early and late development, and for established brands on regulatory components of development specific to cell and gene therapies as well as other tools such as novel endpoints/biomarkers, novel study designs, and digital applications
Effectively represent the Regulatory function in senior level interactions at internal governance technical review committees e.g. Development Review Committee (DRC/eDRC), Early Development Review Board, Global Medical Affairs (GMA) Review Committees
Works in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging science, data and changes in the regulatory environment
Defines and drives disease area global regulatory policies and priorities within the TA
Qualification
Required
Bachelor's degree in life sciences and/or science related field and/or other appropriate knowledge/experience
More than 10 years drug development experience
Broad experience of the therapeutic area, with specific cell therapy immunology regulatory sciences expertise and immune-mediated diseases
Experience in global regulatory strategy and submissions that have progressed through to registration
Must have significant experience in leading major Health Authority interactions
Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority
Experience in managing people in a matrixed organizational structure
Preferred
Advanced degree in a scientific field (e.g. MSc, PhD, PharmD, MD)
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
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