Location: Barcelona - Spain (3 days working from the office and 2 days working from home)
Introduction to the role
Turn groundbreaking science into clear, compelling regulatory narratives that accelerate patient impact. We’re hiring a Associate Director/Director, Clinical Regulatory Writing, to lead communications strategy and delivery for our Cardiovascular, Renal and Metabolism (CVRM) portfolio. In this senior role, you will shape submission strategies for our most complex and business‑critical programs, mentor an exceptional team, and set the bar for communications excellence from development through approval and lifecycle management.
As Director, Clinical Regulatory Writing, you will provide expert leadership for high‑priority clinical programs, driving strategic content development in alignment with product strategy. You will lead the clinical Submission Communication Strategy (cSCS) for complex submissions, guide cross‑functional authoring teams through regulatory interactions up to approval and ensure all clinical‑regulatory documents meet the highest regulatory, technical,



and quality standards. You will be a visible champion for best practice, innovation, and continuous improvement across CVRM.
Accountability
- Lead large, complex, cross‑functional teams to deliver business‑critical submission content and responses, delegating effectively and empowering colleagues.
- Define and own the cSCS for major submissions (e.g., NDA/MAA), aligning messages with label intent and product strategy.
- Ensure consistency, clarity, and compliance across clinical‑regulatory documents; establish and enforce authoring and review standards.
- Steer authoring teams through the regulatory response period to approval, influencing senior stakeholders to adopt best‑in‑class communications practices.
- Represent Clinical Regulatory Writing on key governance and delivery teams, train and coach partners in effective authoring and review.
- Develop and embed innovative best practices,

📌 Associate Director/Director, Clinical Regulatory Writing (España)
🏢 AstraZeneca
📍 España