Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to the role

The RAD provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned product(s). The RAD serves as the general regulatory lead (GRL) on early stage projects or specific indications of larger programs, or as regional regulatory lead. Contributes significantly to overall product and clinical strategy. The role plays a key role influencing Regulatory authorities through regular contacts to improve Regulatory outcomes. The RAD leads cross- functional Teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions, Label discussions, and securing NDA/BLA Approvals. As a GRL the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice.



The RAD serves as the face of the company with Health Authorities.

Typical Accountabilities
- Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes health authority engagement strategy and considerations of expedited regulatory programs.
- Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
- Lead a Global Regulatory Strategy Team (GRST) of k

📌 Regulatory Affairs Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona