Associate DirectorDirector, Clinical Regulatory Writing

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

Introduction to the role

Turn groundbreaking science into clear compelling regulatory narratives that accelerate patient impact. Were hiring a Associate Director/Director Clinical Regulatory Writing to lead communications strategy and delivery for our Cardiovascular Renal and Metabolism (CVRM) this senior role you will shape submission strategies for our most complex and businesscritical 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 highpriority clinical programs driving strategic content development in alignment with product strategy. You will lead the clinical Submission Communication Strategy (cSCS) for complex submissions guide crossfunctional authoring teams through regulatory interactions up to approval and ensure all clinicalregulatory 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 crossfunctional teams to deliver businesscritical 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 clinicalregulatory documents; establish and enforce authoring and review standards.
• Steer authoring teams through the regulatory response period to approval influencing senior stakeholders to adopt bestinclass 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.

Essential skills/experience

• Bachelors 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 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).
• Recognized expert reputation internally or across industry with extensive knowledge of emerging regulatory and technical expectations.

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.

Date Posted

Closing Date

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.