Associate Director, Non-Clinical Data and Documents

Job Title: Associate Director, Non-Clinical Data and Documents

Introduction to role

This Associate Director, Non-Clinical Data and Documents role leads a specialist team that underpins high-quality regulatory submissions, with a focus on SEND data document management and archiving. The position provides day-to-day people leadership and operational oversight to ensure deliverables meet health authority requirements, internal SOPs and the Submission Ready Standard (SRS). It centres on driving excellence in document formatting and house style for submissions, validation error management, archival processes and close support for publishing workflows. Ready to shape how complex data and documents are transformed into submission-ready packages that stand up to scrutiny?

Accountabilities

Lead, coach and manage a team of regulatory operations professionals, setting clear goals, running regular 1:1s and performance reviews, and nurturing a culture of quality, accountability and continuous improvement.

Plan, prioritise and track work across the team to meet submission timelines, SLAs and quality KPIs, removing blockers and escalating risks early to protect delivery.

Oversee document management activities including review and QC, approval and archival in line with SOPs, ensuring robust version control, accurate metadata and full audit readiness.

Own SRS governance by ensuring documents and submission components consistently meet SRS criteria for clarity, completeness, technical compliance and publishing readiness; maintain practical checklists and coach team members on SRS expectations.

Enforce house style and formatting standards for submissions, including templates, controlled terminology and detailed formatting rules (headers/footers, styles, tables/figures, cross-references, bookmarks, hyperlinks, OCR and accessibility) so that documents are truly submission-ready.

Drive systematic validation error management across the team: identify, triage and resolve errors, perform root-cause analyses and implement preventive actions that reduce recurrence.

Provide oversight of Veeva Vault RIM publishing tools for eCTD and other formats, ensuring correct dossier structure, granularity and technical compliance aligned with health authority specifications and internal functional requirements.

Build strong relationships with stakeholders including submission SMEs and SEND/archival experts; communicate status, risks and mitigations clearly while managing expectations and handovers from direct reports.

Ensure compliance with GxP, data integrity principles and record management standards, maintaining inspection readiness at all times.

Monitor important measures such as first-time-right rates and validation error trends; find opportunities to improve tools, processes and training, contributing to updates of SOPs and work instructions.

Guide nonclinical archiving activities including seek/find/retrieval of records and support the strategy and SOP development for archiving physical raw data from studies.

Essential Skills/Experience

Master’s degree in life sciences, pharmacy, information management, or related field and PhD or equivalent. 
Min 8 years in regulatory operations/publishing/document management, at least 3 years people leadership or team lead experience. 
Demonstrated proficiency with: 
Expertise in using Document Management Systems gained in a pharmaceutical environment, e.g., Veeva Vault (RIM) 
Submission Ready Standard (SRS) application and review practices. 
House style and submission formatting in Word/PDF, including templates, styles, cross-references, hyperlinks/bookmarks, and PDF compliance checks. 
Experience with validation rule sets and error resolution across RAM and publishing tools. 
eCTD structure and technical requirements from major health authorities. 
End-to-end submission planning and dispatch processes. 
Experience working in a GxP environment; audit/inspection support preferred.

Desirable Skills/Experience

Leadership and coaching: Ability to develop talent, set expectations, and manage performance. 
Technical rigor: Strong attention to detail; deep familiarity with validation logic, dossier structure, and document formatting standards. 
Problem solving: Skilled in root-cause analysis, prioritization, and risk mitigation for validation errors and submission issues. 
Communication: Clear written and verbal communication; able to translate technical requirements for diverse stakeholders and direct reports. 
Planning and execution: Strong organization and time management; delivers to tight timelines. 

Publishing tools for eCTD and other submission types (e.g., ISI Toolbox, Adobe Acrobat). 
Document management systems and template libraries; Word/PDF advanced features for submission formatting; QC tools for bookmarks/links. 
Familiarity with raw data archiving requirements including seek/find/retrieval  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge
perceptions. That's why we work, on average, a minimum of three days per week from the office. But thatdoesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca offers the chance to be part of a Regulatory community that works end-to-end across development, translating science into medicines that reach patients faster. Here regulatory professionals influence strategy early, engage directly with evolving technologies and data-driven approaches, and help shape how new therapies are developed and approved. It is an environment that values curiosity, original thinking and constructive challenge, where diverse perspectives are welcomed and leaders actively remove barriers so teams can experiment, learn quickly and keep improving. With clear development paths, a dedicated Regulatory academy and a culture that recognises impact, careers progress at pace while contributing to meaningful outcomes for patients!

Ready to take on this challenge and help redefine what Regulatory can achieve? Apply now.

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.