Do you feel passionate about the possibilities of science to change lives? Do you have experience with Document Management Systems, and knowledge of clinical regulations? If so this maybe the role for you.

Here at AstraZeneca, you’ll have the opportunity to make a difference in people’s lives every single day. As one of the world’s premier biotechnology companies, our mission is centred on delivering life-changing products that advance world health, and help fight and cure disease. AstraZeneca has a dynamic environment that cultivates collaboration and innovation. We attract top minds, and we champion and build top talent.

The Regulatory Documentation Specialist is responsible for facilitating effective and compliant use of AstraZeneca’s electronic Document Management System that is used to lead regulatory information for submissions to Health Authorities globally.

The main point of contact for system users within Clinical, Regulatory, Marketing Company Regulatory Affairs and Outsourcing Partners who require business support.

These responsibilities are met through numerous approaches such as:

• Act as the main point of contact for Clinical and Regulatory community who require system access and/or business support
• Run the system security model by maintaining and develop access limitation to documents based on and in line with business needs
• As a subject matter expert, lead and facilitate document management system and process training. Either through assigning significant training in the Learning Management System or delivering virtual presenter-led training sessions
• Analyse queries from the user community to identify trends to improvement opportunities in Training Materials and business processes
• Lead and administer metadata for Regulatory Information through Governance and development of clinical, safety and regulatory naming convention and dictionaries
• Initiate system change requests on behalf of supported users based on valid business needs

Main Responsibilities

• Assign mandatory training
• Manage appropriate access to restricted documents
• Main business point of contact for Clinical, Regulatory and Regulatory Marketing Company users to resolve Document
• Maintain complex dictionaries/metadata
• Facilitate and be the link between business and IS support
• Work with Clinical and/or Regulatory teams and process owners to develop and support business processes
• Provide face-to-face and/or Virtual training to supported users globally
• Participate in the reviewing of the training material

Competitive remuneration and company benefits apply

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applications for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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.