vor 14 Tagen

International Regulatory Affiliate Specialist

gloor & lang ag life science careers

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Our client is a major pharma player in Basel with a distinctive and unmistakable image, carrying very strong brands. As support in the international RA department, we are looking for an ad interims person with first RA experiences in international environment.

International Regulatory Affiliate Specialist

Our client is a major pharma player in Basel with a distinctive and unmistakable image, carrying very strong brands. As support in the international RA department, we are looking for an ad interims person with first RA experiences in international environment.

 In this role you support the activities of the therapeutic area teams in Switzerland acting as an interface between Regional and Local Regulatory Affairs staff. You will ensure that the Local Regulatory Affairs staff have the information and documents requested to register new products and to keep existing registrations up to date through maintenance activities, under the UI dossier owners’ supervision. You do actively support compilation of new registration dossiers and variations, coordinate renewal requests and report on affiliate regulatory activities for Regional and CH Strategy. You will compile the regulatory contribution for PBRERs/PSURS and support the regulatory part of the Product Quality Review (PQR).

Your profile:

  • Business or Scientific diploma or degree
  • 1-3 years experience in a regulatory role
  • TOPRA (Introductory course) or similar preferred
  • Knowledge of European regulatory guidelines

You have the ability to work effectively within a cross-functional team as well as strong customer orientation. We are looking for a flexible person, able to rapidly size up situations and to quickly introduce products on the market, through efficient proposals and effective working procedures.

You have a very good command (speak and write) of the English language and very strong organizational skills. Step into a highly respected and major team-player role in a fast-moving global environment.

gloor & lang ag life science careers
Herr Luca Rohr
Team Assistent
Bahnhofstrasse 31
5405 Baden
+41 61 206 61 81