Associate Director / Director, Clinical Regulatory Writing

About the role

AstraZeneca is hiring an Associate Director / Director, Clinical Regulatory Writing, in Barcelona to lead communications strategy and delivery for its Cardiovascular, Renal and Metabolism (CVRM) portfolio. The role shapes submission strategies for complex, business-critical programs, mentors a team and sets the standard for communications excellence from development through approval and lifecycle management. Working pattern: 3 days in the office and 2 days from home.

Key responsibilities

• Provide expert leadership for high-priority clinical programs and drive strategic content development aligned with product strategy.
• Lead the clinical Submission Communication Strategy (cSCS) for complex submissions such as NDA/MAA, guiding cross-functional authoring teams through regulatory interactions up to approval.
• Ensure clinical-regulatory documents meet the highest regulatory, technical and quality standards, and define and enforce authoring and review standards.
• Steer authoring teams through the regulatory response period to approval and influence senior stakeholders to adopt best-in-class practices.
• Represent Clinical Regulatory Writing on key governance and delivery teams, train and coach partners, and mentor Associate Directors and Managers.
• Develop and embed innovative best practices, tools and processes that improve quality, speed and impact.

Required profile

• Bachelor's degree in Life Sciences or a 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.
• In-depth knowledge of relevant technical and regulatory requirements, with a track record of label-focused documents under tight deadlines.
• Desirable: advanced scientific degree (e.g. PhD) and an expert reputation internally or across the industry.