Director, Clinical Regulatory Writing

Are you ready to translate groundbreaking science into strategic regulatory messaging that drives successful submissions and approvals? We’re hiring a Director, Clinical Regulatory Writing, to lead communications strategy and delivery for our Cardiovascular, Renal and Metabolism (CVRM) portfolio.

As the Director of Clinical Regulatory Writing, you'll be at the forefront of driving strategic communication excellence to achieve successful submissions and approvals. Our team provides expert communications leadership to drug projects, crafting clinical-regulatory documents that align with project strategies and regulatory requirements. You'll be engaged in multiple high-priority programs, acting as both a leader and coach, advocating for the team and fostering an environment of productivity and engagement. Your role will involve developing communication strategies, optimize document delivery, and supporting talent growth within CVRM across all phases of clinical development. You will be a visible champion for best practice, innovation, and continuous improvement across the therapy area.

This role is based at AstraZeneca’s dynamic R&D site in Gothenburg, where you will join an international, collaborative and cross‑functional environment.

Accountability

• Provide expert leadership across a group of submissions or programs, overseeing the communication strategy.

• Lead submission activities and author documents within a program.

• Review key submission documents for consistency of messaging.

• Influence stakeholders at the highest levels of the organization to establish best communications practices.

• Represent Clinical Regulatory Writing on various improvement workstreams and external activities.

• Drive resourcing strategy within area of accountability.

• Support recruitment and onboarding activities for new members of the group.

• Develop and embed innovative best practices, tools, and processes that elevate quality, speed, and impact.

• Support talent growth through mentoring and coaching, acting as a role model for the function.

Essential skills/experience

• Bachelor’s degree in Life Sciences or related discipline, PhD is strongly preferred.

• 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.

Desirable skills/experience

• Advanced scientific degree (e.g., PhD).

• Experience in using AI tools for medical writing

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.

Ready to lead communications that make a difference? Apply by March 31st, 2026.

Date Posted

18-mars-2026

Closing Date

31-mars-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.