AstraZeneca · 20 hours ago
Senior Regulatory Affairs Director - Oncology
Boston, MA
Full-time
Hybrid
Director/Executive
$212K/yr - $317K/yrAstraZeneca is committed to bringing life-changing Oncology medicines to patients worldwide. The Senior Regulatory Affairs Director will lead the Global Regulatory Strategy Team and develop strategies for complex oncology programs while establishing relationships with key stakeholders.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team
Ensure that the strategy is crafted to deliver approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients
Lead the assessment of emerging data against aspirations and update Leadership on project risks/mitigation activities
Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic advice and accountable for all regulatory activities
Own the delivery of all milestones on your team including assessment of the probability of regulatory success based on a detailed assessment of risks and mitigations
Demonstrate strategic leadership skills thereby contributing to effective product development
Promote novel regulatory initiatives internally and engage externally on the corresponding topics. Lead the development of novel tools and technology
Partner and influence developing views/guidance on a global scale
Qualification
Required
An advanced degree in a science related field and/or other appropriate knowledge/experience
Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired
Previous experience in leading major health authority interactions
Solid knowledge of regulatory affairs within several therapeutic areas in early and late development
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred
Proven leadership experience
Ability to think strategically and critically and evaluate risks to regulatory activities
Deep understanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs
Preferred
Experience in the development or application of radio-conjugates would be highly advantageous
Previous experience with FDA advisory committee and EMA oral explanation hearings would be a plus
Previous experience working on due diligence activities and in a business alliance environment
Ability to work strategically within a complex, business critical and high-profile development program
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.
Founded in 1999
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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