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 Regulato

📌 Associate Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona