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

Introduction to role

The Director, Clinical Regulatory Writing (Program Lead) provides expert communications leadership across clinical programs and drives effective collaboration and growth within Clinical Regulatory Writing.

Accountabilities
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best practices. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.
Clinical Regulatory Writing Program Leads are often engaged in multiple, complex, and high priority programs simultaneously, acting as the lead clinical regulatory writer themselves and as a coach for other leads (eg, Submission Leads)



and Clinical Regulatory Writers, being advocates for the team and creating an engaged and productive environment. Clinical Regulatory Writing Program Leads can operate across multiple indications within a single drug program or across different drug programs within the TA. The Clinical Regulatory Writing Program Lead develops communications strategies to guide these programs while advocating and developing best practices for document and submission delivery, representing strategic communications expertise in business process optimisation and improvement initiatives, and supporting the growth and development of talent.
The Clinical Regulatory Writing Program Leads in this role may also be line managers, accountable for coaching and mentoring their direct reports fairly and providing strategic direction and highlighting new opportunities at the individual and departmental level.

The Clinical Regulatory

📌 Associate Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona