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Senior Publishing Associate - eCTD Submissions

  • Location

    London, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    22874_1614094093

  • Published:

    3 days ago

  • Consultant:

    Matt Thomas

Job title: Senior Publishing Associate - eCTD Submissions

A pharmaceutical business in North London are seeking an experience regulatory affairs individual with extensive eCTD submissions experience. This role will support UK and EU teams by publishing and dispatching eCTD (CTD) submissions.

Responsibilities:

  • Build, dispatch and archive eCTD (CTD) major (initial) and lifecycle management submissions, ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance
  • Develop and maintain working knowledge of internal and external publishing standards
  • Archive published dossiers and administrative data on appropriate file-shares
  • Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions
  • Develop, implement and QC review of submission standards.
  • Participate in Global Regulatory Affairs project teams

Requirements:

  • Proficiency in publishing regulatory submissions and using regulatory e-submission software
  • Minimum 2 years' experience in the Pharmaceutical Industry
  • Knowledge and understanding of EU and ICH publishing regulations and guidelines
  • Proficiency in publishing regulatory submissions and using regulatory e-submission software

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

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