Regulatory Publishing Administrator

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Regulatory Publishing Administrator

Posted date | 26/05/2017 Closing date | 30/06/2017
Full Time Experienced

Regulatory Publishing Administrator

A job vacancy for a Regulatory Publishing Administrator has arisen within the pharmaceutical industry. Your responsibilities will include: 

  • Organising documents pertaining to regulatory submissions to health authorities along with other operational duties
  • Supporting with the definition of electronic documents management along with SOPs
  • Liaising with colleagues both locally and internationally whilst formatting documents to ensure they comply with electronic and paper standards
  • Verifying that documentation is complete and meets submission-ready standards
  • Ensuring that regulatory publishing standards for electronic and paper submissions meet standards required by regulatory agencies and in accordance to the company's standards
  • Demonstrating understanding of systems such as eCTDXpress, ISI Publisher, First Doc, ISI Writer, and MS Word Macros.
  • Utilizing database tracking system to support the RA Function

Education & Experience

The vacancy requires a:

  • Have a Bachelor’s Degree (no experience required, IT or Science is an advantage but not a prerequisite)  OR
  • Diploma with minimum 1-2 years’ experience working in Regulatory Affairs/Regulatory Affairs Operations

Skills

  • Strong attention to detail 
  • Highly organized and responsible having excellent written and verbal communication skills in both Maltese and English language
  • Experience with Adobe Acrobat, document scanning, and electronic document management (Documentum, SharePoint or equivalent) 
  • Possess technical abilities (e.g. word processing, MS Word Macros, spreadsheets, databases, online research)

Our client, a multinational company operating in Malta with increased activity in its manufacturing and trading operations.

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