Associate Director/Director, Clinical Regulatory WritingAstraZeneca · Spain - Barcelona
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AstraZeneca

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Associate Director/Director, Clinical Regulatory Writing

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🗓️ Posted 2026-09-28 Spain - Barcelona Full-time Hybrid Healthcare Medical
💰 Salary Not shared 📊 Market 4,500 GBP–8,000 GBP/mo

About the Company

Turn groundbreaking science into clear, compelling regulatory narratives that accelerate patient impact. We're hiring a Associate Director/Director, Clinical Regulatory Writing, to lead communications strategy and delivery for our Cardiovascular, Renal and Metabolism (CVRM) portfolio. In this senior role, you will shape submission strategies for our most complex and business critical programs, mentor an exceptional team, and set the bar for communications excellence from development through approval and lifecycle management. As Director, Clinical Regulatory Writing, you will provide expert leadership for high priority clinical programs, driving strategic content development in alignment with product strategy. You will lead the clinical Submission Communication Strategy (cSCS) for complex submissions, guide cross functional authoring teams through regulatory interactions up to approval and ensure all clinical regulatory documents meet the highest regulatory, technical, and quality standards. You will be a visible champion for best practice, innovation, and continuous improvement across CVRM. Accountability Lead large, complex, cross functional teams to deliver business critical submission content and responses, delegating effectively and empowering colleagues. Define and own the cSCS for major submissions (e.g., NDA/MAA), aligning messages with label intent and product strategy. Ensure consistency, clarity, and compliance across clinical regulatory documents; est

Requirements

  • ● 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.
  • ● In depth knowledge of relevant technical and regulatory requirements; track record of delivering high quality, label focused documents under tight timelines.
  • ● Advanced scientific degree (e.g., PhD).
  • ● Recognized expert reputation internally or across industry, with extensive knowledge of emerging regulatory and technical expectations.
  • ● You'll influence pivotal regulatory outcomes for programs that address some of the world's most prevalent diseases. You'll lead at scale, shape standards, and grow future leaders, while collaborating with world class cross functional teams committed to scientific excellence and patient impact.
  • ● Date Posted 28-sept-2026
  • ● Closing Date 11-oct-2026
  • ● AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Credential Requirements for United Kingdom
🔴

PLAB 1 + PLAB 2

General Medical Council

Must have to work
Cost: GBP 1,000–2,000 Timeline: 6–18 months
🔴

NMC CBT + OSCE

Nursing and Midwifery Council

Must have to work
Cost: GBP 1,000–2,000 Timeline: 6–12 months
🔴

GPhC OSPAP

General Pharmaceutical Council

Must have to work
Cost: GBP 6,000–10,000 Timeline: 1 year
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GDC ORE Part 1 + Part 2

General Dental Council

Must have to work
Cost: GBP 2,000–4,000 Timeline: 1–2 years