Job Description

Would you like the opportunity to work in a global team environment? Do you have experience of working with end-to-end document and submission publishing within the global or Canadian environment? Then this might be the right role for you!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 Manager to our site in Mississauga, Canada.The Regulatory Operations Manager (ROM) is an expert in end-to-end document and submission publishing. The ROM is also an expert 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, including Canadian expertise, on requirements for electronic document management, submission compilation and publishing.
• Experience planning, preparation, and delivery of regulatory submissions throughout the product\'s life cycle.
• Experience performing document (report-level) and submission (eCTD) regulatory publishing for all submission types
• Demonstrated ability to work collaboratively in a global 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 manages routine quality, resource and performance issues to resolution.
• Demonstrated ability to work independently and to set and manage 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 stakeholders.
• Ability to provide subject matter expertise and support for Canadian end-to-end document and submission publishing.
• Ability to flex accountabilities as publishing model evolves.
• Ability to use project management principles and techniques.
• Excellent English written and verbal communication skills.

Desirable Requirements

• 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 with electronic document managements systems.
• Good problem and conflict resolution skills.

Date Posted 03-Jul-2024Closing Date 07-Aug-2024AstraZeneca 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.

AstraZeneca