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Project Manager for Regulatory Operations

Keyrus Biopharma

Brabant Wallon, Belgium

Role and main tasks:

  • Be the business representative contributing to the implementation of the new proactive process for the Market Specific Requirements supporting the submission of all dispatched dossiers to the local authorities (and replacement of the current IT system);
  • Define the technical business requirements (and KPI reporting) needed to implement a new proactive RA process;
  • Contribute to the writing of the URS related to the new IT system supporting the new RA process;
  • Contribute to the selection of the provider of this new IT system;
  • Ensure the execution of the (pre) tests required before starting the final implementation of the new designed IT system;
  • Coordinate the writing/approval of the RA documentation (SOP’s – userguides…) supporting the new process;
  • Ensure the planning of each major phase in partnership with IT representative;
  • Ensure the communication/training with the different stakeholders in partnership with IT representative.

Profile:

Education, Methodology & Certification requirements:

  • University Degree in biotechnology, agronomy, chemistry, pharmacist or engineering;
  • Prince 2 or PMP certified.

Required skills:

  • At least 4 years in pharmaceutical industry, in manufacturing, QA, IT or similar position;
  • Sound knowledge of project management (PMI, Prince2…);
  • Significant experience in driving and directing large projects including management of people from very different environments;
  • Experience in communicating to various stakeholders (good cultural awareness);
  • Experience in defining KPIs & dashboards;
  • Experience in higly regulated environment;
  • Experience as a user representative;
  • Knowledge of change management processes;
  • Capacity to develop functional specifications and system design specifications;
  • Fluent in English;
  • Fluent in French;
  • Practical knowledge of MS project;
  • Experience with Excel and VBA;
  • Knowledge of SAP.

Soft skills:

  • Logical/process oriented approach;
  • Good communication, presentation and influencing skills;
  • Great motivation and team spirit;
  • Autonomous;
  • Customer oriented.

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