Senior Regulatory Affairs Director – Oncology
Location: Boston, Massachusetts, USA
Job ID: R-236242
Date Posted: 04 Nov 2025
Closing Date: 18 Nov 2025
About the Role
AstraZeneca is seeking a strategically focused Senior Regulatory Affairs Director (SRAD) to play a key leadership role in bringing life-changing oncology medicines to patients. The SRAD will serve as the Franchise Global Regulatory Lead (GRL), driving regulatory strategy across complex oncology programs with multiple indications.
You may additionally act as a Regional Regulatory Lead depending on location. This is a senior, high-impact leadership role within the Oncology Regulatory Science and Strategy (ORSS) organization.
About AstraZeneca
Patient-first approach
Entrepreneurial, collaborative culture
Focus on unmet medical needs
Strong oncology pipeline
Emphasis on innovation, speed, and scientific excellence
Oncology Regulatory Science & Strategy (ORSS)
Works across global oncology programs
Drives innovative regulatory approaches
Ensures efficient and effective pathways to bring medicines to patients
Collaborates with cross-functional teams across the business
Key Responsibilities
Leadership & Strategy
Lead a Global Regulatory Strategy Team (GRST) including GRLs, regional members, RA CMC, Labelling, and submission teams.
Develop regulatory strategies enabling timely approval with competitive labeling.
Evaluate emerging data; communicate risks and mitigation plans to Leadership.
Represent Regulatory Affairs on Global Product Teams (GPTs) with full accountability for regulatory activities.
Lead delivery of all regulatory milestones and assess probability of regulatory success.
Innovation & External Influence
Drive and promote novel regulatory initiatives within the company.
Engage externally to influence global regulatory guidance and shape policy.
Lead development of new tools and technology to support regulatory science.
Execution & Collaboration
Ensure strategic alignment across global, regional, and local regulatory teams.
Provide expert regulatory direction for oncology products across early and late development.
Shape overall development strategy for complex or novel programs.
Required Qualifications
Education
Advanced degree in a science-related field (or equivalent experience).
Experience & Skills
Proven regulatory drug development experience, including product approval/launch.
Successfully led at least one major global regulatory approval, including labeling negotiations.
Experience leading major Health Authority interactions.
Broad experience across multiple therapeutic areas in pharma, ideally including oncology.
Knowledge of small molecules and biologics development.
Strong strategic thinking and risk assessment capabilities.
Deep understanding of global regulatory science and drug development processes.
Demonstrated leadership and ability to influence across teams.
Desirable Qualifications
Experience with radio-conjugates.
Experience with FDA advisory committee or EMA oral explanation hearings.
Due diligence or business alliance experience.
Ability to drive strategy in high-profile, complex development programs.
Why AstraZeneca?
A Great Place to Work with strong values and culture
Encourages innovation and entrepreneurial thinking
Inclusive, diverse, and collaborative environment
Strong commitment to employee growth and development
Hybrid working model: 3 days/week in office
Compensation & Benefits
Annual base salary: $211,581.60 – $317,372.40
(Exact pay depends on location, experience, and skills)
Short-term incentive bonus
Equity-based long-term incentive program (for salaried roles)
Retirement benefits (401k)
Paid vacation, holidays, and leaves
Medical, dental, prescription, and vision coverage
“At-will” employment; compensation may change based on performance and market factors
Equal Opportunity Statement
AstraZeneca is committed to an inclusive environment where all applicants are welcome regardless of protected characteristics. Applicants requiring accommodation should complete the dedicated section in the application form.
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