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.
The Regulatory Operations Manager (ROM) is forward-thinking in end-to-end document and submission publishing. The ROM is also a leader in understanding Health Authority requirements as well as the regulatory requirements regarding technical and formatting aspects of global regulatory submission publishing.

Essential Requirements

• Ability to provide global expertise on requirements for electronic document management, submission compilation and publishing.
• Demonstrated ability to work collaboratively in a distributed team environment and to have good project management skills
• Demonstrates a broad solid understanding of process improvement methodologies, tools, techniques and their application.
• Demonstrate an understanding of the characteristics in building successful supplier relationships, supervises Service Level Agreements (SLAs) and leads routine quality, resource and performance issues to resolution.
• Ability to work independently and to set and handle priorities, resources, performance targets and project initiatives in a global environment.
• Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulations and mentorship and clearly communicate requirements to immediate collaborators.
• Ability to use project management principles and techniques.
• Excellent English written and verbal communication skills.
  

Desirable Requirements

• Experience from planning, preparation and delivery of submissions throughout the product's life cycle.
• Experience from analysing queries from the user community to identify improvement opportunities in Systems, Cue Cards, Training Materials and business processes.
• Experiences from providing support in assisting users with questions related to end-to-end document and submission publishing.
• Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions.
• Experience of system administration for validated applications within a regulated environment.
• Experience from electronic document managements systems.
• Good problem and conflict resolution skills.

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 committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca?s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process. 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.