Regulatory System Owner

€80000 - €85000 per annum
  1. Permanent
Les Ulis, Île-de-France
  1. Regulatory Affairs, Operations
Posted: 22/02/2021
BBBH15968

This vacancy has now expired. Please see similar roles below...

Hobson Prior are currently working with a worldwide specialty-driven biotech company who are looking for a Regulatory System Owner to join them on a permanent basis Les Ulis.

Please note that to be considered for this role you must have the right to work within this location.

Job Responsibilities:

Users Interactions:

  • Accountable to perform continuous contacts and exchanges with Business Partners of the Regulatory Tools.
  • Direct users towards existing supportive materials.
  • Promote consistent use of Tools through clear communication.

Participation to the management of tools evolution:

  • Assess Vendor releases and provide analysis results and impact assessment to the Systems team.
  • Support the delivery of systems / upgrades and new implementation projects.
  • To provide investigation and analysis of user requirements, including but not limited to requirements definition, solution design, configuration and administration plan.
  • Ensure consolidation of users/process needs/requirements in close collaboration with the Systems team, the IT team and the vendor: Centralise requirements, ensure regulatory impact assessment and validation by "change control board" and validate the implementation of the evolution.
  • Execute informal and formal tests, or ensure they are performed.

Manage Systems Support Forums or User groups meetings:

  • To suggest the agenda.
  • Suggest the supportive slides.
  • Lead the meeting.
  • Ensure the delivery of Reports from Systems (Extracted Data).
  • Understand Business needs.
  • Build and Deliver standardized Reports.
  • Any other assigned duties.

Key Skills:

  • Proficient English, written and oral, if not mother tongue.
  • Excellent written and oral communication skills capable to deliver key communication with precision and impact.
  • Good organizational skills, social and negotiation skills.

Requirements:

  • To have a degree in Life Science or IT.
  • Excellent knowledge on Regulatory Systems: EDMS, Publishing System, Tracking System.
  • To have extensive knowledge of Microsoft Pack Office.
  • Previous experience with Regulatory Systems for more than 1 year and experience in Systems administration.
  • Previous experience of matrix working.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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