Job title: Senior Publishing Associate

A pharmaceutical business in North London are seeking an experience regulatory affairs individual with extensive eCTD submissions experience. This role will support UK/IE teams by building and dispatching life cycle management submissions.

Responsibilities:

• Build and dispatch eCTD lifecycle management submissions, ensuring that all final electronic deliverables meet current regulatory electronic document requirements
• 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

Requirements:

• 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