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Job Details

Regulatory Affairs Officers - Ireland

Company: Umbilical Life
Location:
Reference: IR - Reg -22
Closing Date: 26 Feb 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Avni Bhayani at Umbilical Life is recruiting permanent experienced Regulatory Affairs Officers for a pharmaceutical company based in Ireland. The ideal candidate will have at least 2 years regulatory experience in the pharmaceutical industry, a life science or pharmacy background and a sound knowledge of European submission procedures and electronic applications.

Requirements:

Core Responsibilities

  • Authorising responses to questions from authorities
     
  • Providing regulatory support for out-licensing activities in EU and non EU territories
     
  • Planning and tracking of regulatory procedures through the completion in a timely manner
     
  • Management of a specific portfolio of products

Responsibilities

  • Preparation and submission of variations, renewals and transfers
     
  • Liaising with other internal departments and external parties to generate data for submissions
     
  • Reviewing Compliance documentations MA guidelines.

 

Experience

  • Practical experience of registration and variation procedures in the EU (national/MRP/DCP)
     
  • Good understanding of the content and format of MA registration files (CTD)
     
  • Knowledge and understanding of the requirements for product information (QRD template)
     
  • Understanding of the application of change control to regulatory procedures
     
  • Knowledge and understanding of the EU regulatory framework

Apply for this job: Regulatory Affairs Officers - Ireland

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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