Regulatory Information Manager at AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
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.
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.
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-01-18. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Alma Zanqrelle
alma.zanqrelle@dfind.se or Eleonor Ehrman 0733-434109
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the work second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-12-20ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-01-18
Ange följande referens när du ansöker: 201111646
Klicka på denna länk för att göra din ansökanKontaktEleonor Ehrman
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 3866769
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