Regulatory Operations Manager (Publishing)

Responsibilities:

  • Regularly providing Regulatory Operational support to the internal Reg Affairs team 
  • Supporting implementation, staff training and maintenance of the Company’s Regulatory Information and Electronic Document Management Systems
  • Regulatory project management support to Reg Affairs team while ensuring effective completion of regulatory submissions and deliverables. 

 

Requirements:

  • Educated to degree level, Bachelor of Science;
  • High level of experience within Regulatory Operations (within the pharmaceutical industry)
  • Previous Vendor Management & Project Management experience (within the pharmaceutical industry)
  • Direct involvement in and knowledge of the preparation and filing of EU MAAs, be familiar with CTD requirements and ICH guidelines. 

 

 

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Agency providing Global Staffing services.

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