AstraZeneca seeks an Associate Director/Director of Clinical Regulatory Writing to lead submission strategy and communications for the Cardiovascular, Renal and Metabolism portfolio. This senior role involves managing complex cross-functional teams, defining clinical submission communication strategies, and mentoring regulatory writing leaders through drug development and approval.
Responsibilities
- Lead large cross-functional teams delivering business-critical submission content and regulatory responses
- Define and own clinical Submission Communication Strategy for major submissions aligned with product strategy
- Establish authoring and review standards ensuring consistency, clarity, and regulatory compliance
- Guide authoring teams through regulatory response periods to approval and influence stakeholder adoption of best practices




- Mentor and develop Clinical Regulatory Writing leaders and act as role model for the function

Requirements
- Bachelor's degree in Life Sciences or related discipline
- Significant medical or regulatory writing experience in pharma, biotech, or CRO
- Proven ability to lead complex communication programs and submission teams
- Strong understanding of drug development and end-to-end communications processes
- In-depth knowledge of technical and regulatory requirements for high-quality document delivery
- Advanced scientific degree (e.g., PhD) preferred
- Recognized expert reputation with knowledge of emerging regulatory expectations preferred

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