Regulatory Operations Manager to AstraZeneca Gothenburg

about the consultant assignment
The Arena:
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 for one consultant for the role as Regulatory Operations Manager (ROM) to our site in Gothenburg, Sweden.

The position is a temporary assignment lasting until 2018-08-31.

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.

Who you are
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.

About Poolia Life Science & AstraZeneca
Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.

Next step, apply today!


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