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Senior Reg Affairs Associate, Publishing

Job Title: Senior Reg Affairs Associate, Publishing
Contract Type: Permanent
Location: Hertford, England
Industry:
Salary: £35000 - £45000 per annum
Start Date: 2019-10-15
Reference: BH-117499
Contact Name: Max Robinson
Contact Email: max.robinson@nesgt.com
Job Published: October 16, 2019 14:20

Job Description

Senior Reg Affairs Associate - Submissions Publishing - Pharma - South East

A new role has arisen for a Senior Regulatory Affairs Associate focusing on submissions publishing for a global pharma company based in West Essex and commutable from London and Hertfordshire. Do you have experience in Regulatory Submissions and are interested in the opportunity to challenge yourself in a dynamic environment?

Senior Reg Affairs Associate, Submissions Publishing Responsibilities

  • Publishing electronic regulatory submissions following eCTD and ICH standards for MAA and post market approvals
  • Preparing and submitting full eCTD lifecycle management submissions
  • Working closely with other Regulatory Affairs teams for the preparation and publishing of regulatory submissions
  • Updating internal working schedules as well as solving submission document issues
Senior Reg Affairs Associate, Submissions Publishing Requirements

  • Degree or equivalent experience in a Scientific or IT discipline
  • Experience in pharmaceutical regulatory affairs
  • A good knowledge the processes required to publish regulatory submissions electronically
  • High level of computer and MS Office proficiency
In return you can expect a competitive salary and package as well as the opportunity to progress your career in a global organisation