Executive Regulatory Science & Strategy Director, Oncology
AstraZeneca
Pharmaceutical Industry
Barcelona, Cataluña - Spanien
Manager / Team Leader
Experteer Overview
In this role you shape global regulatory strategy for oncology products, leading the Hematology-focused Regulatory Science team. You will mentor regional and global leads, partner on innovative regulatory approaches, and steer submissions and health authority interactions. You’ll drive risk planning, policy development, and high-level governance, ensuring timely, compliant registrations across small molecules and biologics. This is a strategic, cross-functional role that directly impacts patient access to life-changing cancer medicines and the organization’s regulatory excellence.
Responsibilities
- Coach and mentor regional and global regulatory leads, identifying development opportunities
- Partner with Regulatory Affairs Directors on global regulatory strategies
- Lead resource planning and staff recruitment
- Provide input on disease area regulatory strategies, risk planning and mitigations
- Represent Global Regulatory Affairs in governance reviews, health authority meetings, and external partnerships
- Collaborate with policy and intelligence groups to assess emerging science and regulatory changes
- Define and drive global regulatory policies and priorities
- Review and approve high-level global regulatory submissions and core prescribing information
- Ensure submission excellence framework is consistently applied across projects
- Sponsor non-drug project workstreams and external activities
Key requirements
- Bachelor’s degree in life sciences or related field
- More than 10 years drug development experience
- Oncology therapy area knowledge with Hematology assets preferred
- Deep knowledge of global regulatory strategy across all phases of oncology development and marketing applications
- Significant experience in leading health authority interactions
- Experience growing high-performance teams in a matrixed environment
- Strategic and critical thinking to evaluate regulatory risks and decisions
- Ability to travel domestically and internationally
Description
In this role you shape global regulatory strategy for oncology products, leading the Hematology-focused Regulatory Science team. You will me…
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