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The Arena:

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.

AstraZeneca turns ideas into life changing medicines. Working there means being entrepreneurial, thinking big and working together to make the impossible a reality.

The role:

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.
Business:
Dfind Science & Engineering

City:
Gothenburg

Deadline for applications:
2017-01-25. 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.
Mer info
Område Göteborgs stad
Yrkesroll Teknik & Ingenjör, Ingenjör, Kemi, Fysik & Biologi
Typ av anställning Heltid
Hemsida http://www.dfind.se
Sista ansökningsdag 25 jan (5 dagar kvar)

Om arbetsgivaren

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 you might be the right candidate for this consultant assignment as regulatory operations manager to their site at Gothenburg.