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Regulatory Publishing Specialist

Introduction

Report Publishing Associate will support authors to publish submission ready documents by applying appropriate compliance check to the type of document, publishing the document & also performing the QA check for the published document.

Function

Responsibilities:

· Work with various electronic regulatory submission documents (eCTD) in compliance with EU requirements for MRP and national procedures in case of already approved products (regulatory life cycle management):

· Hyperlinking, linking, bookmarking and finalization of documents of Modules 1, 2, 3 4 and 5.

· Formatting, editing, compiling, assembling, publishing, and issuing of eCTD documents.

· Document compliance, batch importing, managing structures, authoring and reviewing.

· Electronically manipulate externally authored reports using Adobe Acrobat and ISI Toolbox to meet submission requirements and to follow internal style guides.

· Ensure all documents are maintained according to departmental SOPs.

· Work in the integrated document management system and publishing tool that streamlines the process for planning, creating, reviewing, compiling, publishing and producing a dossier.

· Coordination and correspondence with other regulatory departments in the EU.

Requirements

· Bachelor’s Degree in Life Sciences

· Good typing and computer skills including practical experience with MS Office

· Preferably 1-2 years of relevant experience in pharmaceutical regulatory

· Ability to work with an integrated document management system and publishing tool which is comprised of a number of integrated software applications (documentation management system, eCTD compilation and publishing system, word-processing application, Adobe Acrobat)

– At least upper intermediate English knowledge

Information

Our people are our greatest asset and we believe the most ef­fective teams reflect diverse backgrounds and ideas. If you are interested in an international and multicultural environment, with young and dynamic colleagues, and good work atmosphere you can join our team by applying to this position.

Application

At TCS you will discover:

  • A colorful and dynamic work environment with a great diversity of people, cultures and business areas
  • An open culture that improves the quality of life
  • Learning and sharing that helps you to progress both professionally and personally