Regulatory Information Management Systems, Manager

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We are currently looking to hire a Regulatory Operations Managers to our site in Mississauga, Canada.

Enterprise Regulatory Vault (ERV) is AstraZeneca's business-wide system for Regulatory Information Management (RIM). As a data-centric cloud / SaaS platform it enables compliance with current regulatory requirements and can evolve to meet future needs. This flexibility brings many benefits, but also the key challenge of a relentless cycle of incremental and continual changes that requires ongoing investment of time and resources to ensure AZ maximizes utility and enables automation, digitization and agility to meet future needs.  

An organisation within GRO exists specifically to manage these key systems (and their associated standards and processes) on behalf of the cross-functional business, ensuring that they are

•   Effectively maintained, developed and supported to meet the needs of the business.

•   Coordinated, accessed and used in accordance with AZ policy and Health Authority requirements

The Manager, Regulatory Information Management Systems plays a key role in supporting the RIM suite of tools, and applies specialized knowledge relating to ensuring that customers gain full value from available information assets.

Typical Accountabilities

• Providing expert system-related mentorship and business support to users [both internal to AZ and external partners] through personal interaction and online ticket management systems
• Working with product owners, business teams and process owners to develop and support business processes pertaining to our RIM platform
• Business administration of systems, e.g. provision of system access, maintenance of master data, application of security models and managing change
• Development of training and user support materials, e.g. job aids, training videos, e-learning
• Management of systems communication methods, e.g. SharePoint, OneNote, MS Teams, Workplace.
• Writing scripts and participating in system testing in support of system releases
• Facilitating and acting as the link between business and IS support
• Cross-training to learn a growing number of systems, taking on additional responsibility
• The successful candidate will work in a functional matrix environment, reporting to a Section Director, and taking direction from Associate Directors who manage a portfolio of work. 
  

Essential

• Bachelor’s degree or a proven track record of equivalent experience within a commercial environment.
• Experience of business administration for a validated application within a regulated environment, preferably within the pharmaceutical industry.
• Experience of delivering business support and/or training to end users.
• Proficient in written and verbal English.
  

Desirable

• Knowledgeable in the drug development process, including regulatory documentation, submission, publishing and approval processes
• Experience of working with an enterprise-wide Document Management System and/or other Regulatory tools supported by GRO (e.g. publishing software, tracking databases).
• Ability to build relationships across, cultures, functions and disciplines to deliver a quality service
  

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 9 years
• Learn about our culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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 authorisation and employment eligibility verification requirements.