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Regulatory Affairs Project Lead

Are you someone that enjoys building bridges in teams, overseeing big projects and at the same time be a sparring partner for regulatory matters. Then this could be a good opportunity and I welcome you to keep reading.

Job Description
As a Regulatory Affairs Project Lead you are in charge of a project in which new regulations are implemented. You will write project plans while maintaining close contact with stakeholders and plan activities according to project time lines.

Responsibilities

  • Leading a project team to implement new guidelines within Regulatory Affairs
  • Write (and manage) project plans with aim to harmonise and work compliant to latest regulatory requirements
  • Inform stakeholders within different departments
  • Perform impact assessments for already approved products
  • Set time lines and provide planning for team members

Requirements

  • Academic level of education
  • several years of workexperience within regulatory affairs
  • Experience with projectmanagement
  • Experience with systems as CESSP, IDMP, UPD, etc
  • Experience with regulatory information systems (CESSP, Veeva)
  • Excellent communication skills in Engelish
  • You are engaging, oversee projects and understand the different needs from different stakeholders and can navigate within big companies
  • You know how to keep overview and have the capacity to zoom in to details of regulatory matters if and when required

Terms of employment

  • Employment : Contract at Oxford Global Resources Solutions, long term with possibility for permanent contract.
  • Salary indication of 4000-6000 per month on ft basis
  • Independent contractors are welcome
  • Hours : fulltime
  • Location: region of Nijmegen

Vacaturenummer : 15920