Jurek Bemanning

Regulatory Operations Manager to AstraZeneca Gothenburg

Jurek Rekrytering & Bemanning AB is a niche company in recruitment and staffing within law, finance, marketing, administration and HR. Our clients include the biggest companies in Sweden, as well as government authorities and many medium-sized and small enterprises. Basically, we are able to offer all types of job and position.

Astra Zeneca is now looking for a Regulatory Operations Manager for a consulting assignment at AstraZeneca to the end of August 2018. You will be employed by Jurek Rekrytering & Bemanning. If questions you are very welcome to contact Consultant manager Julia Järvholm at julia.jarvholm@jurek.se, or + 31-712 83 50.

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.

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

Essential Requirements
• Experience of system administration for validated applications within a regulated environment.
• Experience from analysing queries from the user community to identify improvement opportunities in Systems, Cue Cards, Training Materials and business processes.
• 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.
• Excellent English written and verbal communication skills.

Desirable Requirements
• Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment.
• Ability to use project management principles and techniques.
• Experience from planning, preparation and delivery of regulatory submissions. Providing support to users with questions related to document and submission publishing.
• Experience from evaluating regulations, guidelines and technical specifications related to publishing/submission processes.
• Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions.
• Experience from electronic document managements systems.
• Good problem and conflict resolution skills.


Västra Götalands län

Visstid Heltid

Julia Järvholm

 Ansök nu

Sista ansökningsdag : 5 maj . Arbetsort : Göteborg

Kategorier : Kontor & Administration

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