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Senior Publishing Associate, Regulatory Submissions

Senior Publishing Associate, Regulatory Submissions

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    18260_1582104818

  • Published:

    7 months ago

  • Expiry date:

    2020-03-20

  • Consultant:

    #

Job title: Senior Publishing Associate, Regulatory Submissions

A global pharmaceutical company based in London are seeking a Senior Regulatory Submissions Associate. This role will be responsible for electronic submissions inline with current eCTD EU and ICH guidelines.

Responsibilities:

  • Management of eCTD lifecycle submissions inline with current guidelines and regulations
  • Cross function collaboration with scientific personnel to ensure quality of submissions
  • Dossier and data file management in accordance with internal SOPs
  • Working with senior management to streamline and improve internal processes

Requirements:

  • Extensive experience within regulatory submissions and e-submission software
  • Bachelor's degree within life sciences
  • Understanding of EU and ICH regulations
  • Ability to manage multiple processes with close attention and high quality

Salary and benefits:

A competitive basic salary and extensive benefits package is on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk