Regulatory Information 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 Regulatory Information? Are you up for a new challenge in the ever-changing environment called RIMs? 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 now looking for 3 consultants for the role as Regulatory Information Manager, to join our team for a 12 month assignment.

Tasks and responsibilities / The Role:
As Regulatory Information Manager you will be an expert in end-to-end tracking and documentation, which includes set-up, follow up and documentation of regulatory submissions and approval information. As a Regulatory Information Manager, you will also be an expert in understanding Health Authority legislation interpretation as well as the regulatory requirements with regard to licenses and clinical trials aspects of tracking and life-cycle management.

To be successful in this role you have to show a demonstrated ability to work collaboratively in a global team environment and have good project management skills. You need the ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment. It is important that you can 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.

Who you are
Essential Requirements:
•Minimum 1 year hands-on experience with tracking of regulatory information.
•University degree or equivalent experience in life sciences or technical field.
•Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals.
•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.
•Experience from planning of large and complex business activities.
•Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application.
•Excellent English written and verbal communication skills.

Desirable Requirements:
If you have previous experience of system administration for validated applications within a regulated environment this would be an advantage as well as knowledge of AstraZeneca submission, publishing, approval processes, tools and standards. Previous experience in using ANGEL applications is also qualifying. The successful candidate have good problem and conflict resolution skills and the ability to see changes as an opportunity to improve performance and add value to the business.

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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