Regulatory Affairs Infrastructure docuBridge Support - Limited 6 months - Zurich

 — Opfikon
06.04.Specialist100%

Regulatory Affairs Infrastructure docuBridge Support - Limited 6 months - Zurich

We are looking for a professional to join our Regulatory Affairs Infrastructure team to work closely with internal and external stakeholders and IT to support our publishing tool in terms of updates/upgrades and to implement new interfaces to other regulatory relevant systems. The person will also support to design and develop regulatory processes to establish efficient new ways of working that will help to drive procedural and operational excellence. The role is based at our operational HQ in Glattbrugg, Zurich, and will be reporting directly to the Head of Regulatory Affairs Infrastructure. 
In this role your tasks will include but not be limited to:
  • Support implementation activities, review and interpret release notes and new functionalities for the business
  • Support the implementation of the docuBridge interface with the eDMS system together with GRA business and IT stakeholders
  • Review existing, design and develop new processes and accommodate to leverage new system interfaces to support product expansion
  • Actively support the enhancement of electronic document management, regulatory submissions
  • Support annual and ad-hoc system upgrades/updates to meet health authority compliance and requirements
  • Further tasks according to directives from Line Manager
The ideal candidate brings the following skills and experience:
  • Degree in a scientific discipline
  • Minimum of 2-3 years' experience in the pharmaceutical industry in a relevant area
  • Knowledge of Regulatory Affairs submission process in particular in eCTD publishing, eDMS and Regulatory Information Management tools
  • Experience of planning and compiling submissions for CH, EU, US and ROW
  • Experience in regulatory system implementation or equivalent
  • Excellent Microsoft Office skills
  • Publisher with experience of using docuBridge is preferred
  • Fluency in English, oral and written; German language skills are a plus
You have excellent communication skills and a solution oriented mind-set. You are capable of translating business requirements into IT requirements, able to identify risks during project implementations, and structure a large amount of information quickly. You have strong collaboration and teamwork skills, being able to work cross-functionally and with multiple stakeholders (internal and external). You set priorities according to needs, resolve issues appropriately and act as a role model for the Vifor Pharma values.

Julia Quentmeier
International Talent Acquisition Specialist

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