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Labeling Regulatory Affairs Specialist

Employer
RBW Consulting
Location
France (FR)
Salary
Competetive
Start date
31 May 2023
Closing date
30 Jun 2023

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

An opportunity has arisen for an enthusiastic and driven individual to join a Biotechnology client as a Labeling Regulatory Affairs Specialist on an interim/contract/freelance basis. This role will be hired a on an 18 month contract. 

In this fast paced organisation you will work closely with the Global Head of Regulatory Affairs to provide strategic direction and create a center of excellence within Regulatory Affairs Labeling. This is an Associate level position, with profiles being considered with 1-5 years of experience.

Please note that this role can be based across Netherlands, France, Ireland, UK & Germany. The role will be English spoken, but additional knowledge of Eastern European languages will be a big plus.

The duties of the Regulatory Affairs Labeling Specialist will be:

  • Management of product information texts and documents across the European Union and International region (ad hoc support for North America may be required). This will require:
  • Close coordination with the regional and global regulatory strategy and regulatory labeling, advertising and promotion teams
  • Gathering linguistic and scientific input from Apellis and distributor company subject matter experts
  • Coordination of translation and regulatory vendor companies to ensure timely and compliant translations, local adaptations and posting on local compendia (such as eMC, Rote Liste, etc.)

The ideal candidate for this position will be qualified with a scientific degree and possess approximately 3 years working within a Regulatory Affairs Labeling post.

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