Director, Clinical Regulatory Writing

Are you ready to translate groundbreaking science into strategic regulatory messaging that drives successful submissions and approvals Were 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 youll 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. Youll 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 AstraZenecas dynamic R&D site in Gothenburg where you will join an international collaborative and crossfunctional 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

• Bachelors 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 endtoend communications process from early development through launch and lifecycle management.

• Indepth knowledge of relevant technical and regulatory requirements; track record of delivering highquality labelfocused documents under tight timelines.

Desirable skills/experience

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

• Experience in using AI tools for medical writing

Youll influence pivotal regulatory outcomes for programs that address some of the worlds most prevalent diseases. Youll lead at scale shape standards and grow future leaders while collaborating with worldclass crossfunctional teams committed to scientific excellence and patient impact.

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

Date Posted

Closing Date