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Manager, Regulatory Publishing

Lieu Mississauga, Ontario, Canada Job ID R-142648 Date de publication 07/05/2022

Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, entrepreneurial thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

To best support our employees in balancing personal and work commitments, we’ve embraced a hybrid model of working that gives employees flexibility in how they manage their time. 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 commitment 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 bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Our position:

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? 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 Managers to our site in Gothenburg, Sweden for an approximately half year assignment.

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 on requirements for electronic document management, submission compilation and publishing.

  • Demonstrated ability to work collaboratively in a global team environment and to have good project management skills

  • Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application.

  • Demonstrate an understanding of the characteristics in building successful supplier relationships, monitors 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 guidance and clearly communicate requirements to immediate stakeholders.

  • Ability to use project management principles and techniques.

  • Excellent English written and verbal communication skills.

Desirable Requirements

  • Experience from planning, preparation and delivery of regulatory 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:

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

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.

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