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, commercialization and life cycle management of the assigned product(s). The RAD serves as the global regulatory lead (GRL) for 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 in 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 regula...