The English-language job board for Spain

SpainJobs.io

Associate Director/Director, Clinical Regulatory Writing

Hybrid in Barcelona·Full-time·Added 5 days ago

AstraZeneca

40 open roles

Apply

Overview

Job details

  • Full-time hours

    Per the ad.

  • Hybrid

    Office and home days — the ad has the split.

Requirements

  • Have the right to work in Spain

    AstraZeneca doesn't mention sponsorship in the ad.

  • Work in English

    English is required, per the ad.

  • Be near Barcelona for hybrid days

    No relocation package mentioned.

  • Have senior-level experience

    Senior-level role.

  • University degree

    “Bachelor's degree in Life Sciences or related discipline.” — per the ad.

Requirements

What we're looking for

  • 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.

Nice to have

  • 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.

The role

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.

What you'll do

  • 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; establish and enforce authoring and review standards.
  • Steer authoring teams through the regulatory response period to approval, influencing senior stakeholders to adopt best‑in‑class communications practices.
  • Represent Clinical Regulatory Writing on key governance and delivery teams, train and coach partners in effective authoring and review.
  • Develop and embed innovative best practices, tools, and processes that elevate quality, speed, and impact.
  • Mentor and develop Clinical Regulatory Writing leaders (Associate Directors and Managers), acting as a role model for the function.

How you'll work

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

Date Posted

28-sept-2026

Closing Date

11-oct-2026

Hiring process

2 steps1 interviewa task to do

  1. Application

  2. Recruiter contact · With a recruiter

  3. Assessment

    Not every role

    Some roles, especially graduate roles, add a game-based assessment, a video or telephone interview, or an assessment day.

  4. Interview

    A two-way conversation about your skills and suitability for the role, and a chance for you to find out if AstraZeneca is right for you.

  5. Pre-employment screening

  6. Offer

  • Candidates who reach interview stage or beyond usually get feedback within 14 days of the role's closing date.
  • Interview travel expenses are reimbursed for journeys over 100km.
  • Alcohol and drug testing is carried out for new hires where required by local country legislation.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that discovers, develops, and commercializes prescription medicines in therapeutic areas including oncology, cardiovascular, renal and metabolism, and respiratory and immunology. With a workforce of over 80,000 employees worldwide, the company is headquartered in Cambridge, UK, and operates across more than 100 countries, focusing on innovative medicines and advanced technologies like AI and data science to transform patient care.

In Spain, AstraZeneca has a significant presence with offices in Madrid and Barcelona, contributing to clinical development, regulatory affairs, and commercial operations. The company is known for its collaborative and inclusive culture, offering international professionals opportunities to work on global projects, particularly in areas like cell therapy, AI-driven health solutions (Evinova), and patient safety. With a strong commitment to diversity and innovation, AstraZeneca Spain is an attractive destination for talent seeking to make a global impact while living in Spain.

Industry
Pharma
Founded
1999
Employees
10,000+
Headquarters
Cambridge, UK
In Spain
Madrid, Barcelona
Website
astrazeneca.es

Good to know if you are moving

  • AstraZeneca offers a global, multicultural work environment with opportunities to collaborate with colleagues across the world.
  • The company has a strong commitment to employee development and offers various career growth programs.
  • Spain offices are located in major cities like Madrid and Barcelona, offering a high quality of life and vibrant culture.
  • AstraZeneca is a leader in innovative therapies, providing employees with the chance to work on cutting-edge medical advancements.
  • The company supports flexible working arrangements and promotes a healthy work-life balance.

In their own words

Additional information

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.

All open roles at AstraZeneca

Location

AstraZeneca · Barcelona

Loads Google Maps, which may set its own cookies.

Tags

More jobs like this

or browse Barcelona·Healthcare·Senior·Hybrid·Healthcare & Pharma·Catalonia·Pharma

WhatsApp

More jobs from AstraZeneca

Related Jobs