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Regulatory Affairs Officer - Dublin

Function Group: Quality/RA / RA Officer

Organization

This young and fast growing organisation is at the forefront when it comes to working in novel ways. In a virtual setting they provide all services when it comes to the development and production generic pharmaceuticals. With clients all over the world they are looking for an ambitious and driven Regulatory Affairs Officer to strengthen the team!

Function

As Regulatory Affairs Officer, it is your responsibility to review and make submissions of the highest quality with regards to chemistry manufacturing and control (CMC) detailed regulatory documents for dossier registrations. Using strong communication skills, both written as well as verbal, you will be able to liaise and work closely with other company personnel (R&D, quality, business development and licensing) and ensure accuracy of such documents while also being able to liaise with external parties such regulatory authorities and affiliates.

To summarise, your day-to-day will consist of:

  • the submission of MAAs (generic/bibliographical) in the EU via national, MRP and DCP routes
  • auditing registration dossiers for the EU in order to evaluate and identify any possible deficiencies prior to assessment and managing post-licensing activities (variations, renewals, PSURs, etc.)
  • providing regulatory support for out-licensing activities in EU and non-EU territories

Requirements

The ideal candidate:

  • Has a minimum of three years of relevant experience in an RA department within the pharmaceutical industry
  • Holds a master’s or honour’s degree
  • Has good working experience with Module three documentation
  • In addition, has experience eCTD compilation
  • Is pragmatic, flexible and communicative, and has a hands-on approach
  • Loves to work on their own initiative and in project teams, this in a high pace, multi-cultural environment

Offer

  • Competitive salary
  • Secondary package
  • The organisation offers good options for career progression (senior level, management level)

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Martin van der Velden
Consultant Clinical Research & Medical Affairs

+31(0)23-7548660
+31(0)6-83656209
m.vandervelden@qtcrecruitment.com

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