Director, Clinical Regulatory Writing — Strategy & Submissions

AstraZeneca plc; Barcelona; Híbrido; EUR 120.000 - 180.000; Jornada completa

Descripción de la vacante

AstraZeneca plc in Barcelona is seeking an Associate Director/Director, Clinical Regulatory Writing to lead pivotal CVRM submission content and strategy. You will mentor teams, shape submissions from development through approval, and drive best-in-class regulatory communications with senior stakeholders.

You will guide cross-functional authoring groups, ensuring regulatory compliance, quality, and timely delivery across complex programs while aligning with product strategy.

Formación

• Bachelor’s degree in Life Sciences or related discipline.
• Significant experience in medical/regulatory writing within pharmaceutical/biotech or CRO environments.
• Proven ability to advise on and lead complex communication programs and submission teams.
• Strong understanding of drug development and the end-to-end communications process from early development through launch and lifecycle management.

Responsabilidades

• Lead large, cross-functional teams to deliver submission content and responses.
• Define and own the cSCS for major submissions (e.g., NDA/MAA).
• Ensure consistency, clarity, and compliance across clinical-regulatory documents; establish standards.
• Steer authoring teams through the regulatory response period to approval.
• Mentor and develop Clinical Regulatory Writing leaders.

Conocimientos

Regulatory writing leadership

Cross-functional leadership

Project management

Strategic writing

Stakeholder engagement

Educación

Bachelor’s degree in Life Sciences

Advanced scientific degree (PhD)

Descripción del empleo

AstraZeneca plc in Barcelona is seeking an Associate Director/Director, Clinical Regulatory Writing to lead pivotal CVRM submission content and strategy. You will mentor teams, shape submissions from development through approval, and drive best-in-class regulatory communications with senior stakeholders.

You will guide cross-functional authoring groups, ensuring regulatory compliance, quality, and timely delivery across complex programs while aligning with product strategy.