Regulatory Operations Publishing Associate

Regulatory Operations Publishing Associate

A job vacancy for an Regulatory Operations Publishing Associate has arisen within the pharmaceutical industry. Your responsibilities will include: 

·  Publishing regulatory submissions using electronic publishing systems while supporting with the preparation of electronic submissions and scanning of documents

·  Assisting with the definition of electronic document management and submission publishing processes and SOPs

·  Verifying that documentation is complete and meets submission-ready standards

·  Ensuring that all documents are filed and archived properly in accordance with regulatory agency requirements

·  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

·  Formatting documents to ensure they comply with electronic and paper standards

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.