We are, on behalf of our customer Astra Zeneca in Gothenburg looking for a Regulatory Operations Manager. Please state ref. 750084 if you respond to this request.
The position is a temporary assignment lasting until 2019-06-30.
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 now have a temporary position as a Regulatory Operations Manager 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.
- 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.
- 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.