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Senior Regulatory Affairs Director - Oncology

0-2 years
$211,581.60 – $317,372.40
10 Nov. 17, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.