Drug Regulatory Affairs Coordinator

Drug Regulatory Affairs Coordinator wanted for our Zug based client in the pharmaceutical sector.

YOUR EXPERIENCE/SKILLS:

- Several years' experience in a regulatory role
- Expertise in Regulatory Affairs, Label Changes and CMC submissions
- Experience with Swissmedic
- Languages: fluent English and German both written and spoken

YOUR TASKS:

- Coordinating and preparing regulatory submissions for assigned products to Swissmedic for Safety Label Updates and new Indications
- Keeping renewals up-to-date and submitting applications for renewals if required
- Coordinating the process of artwork creation and approval and performing text comparisons of artwork components, including final release of Ready for Print (RfP) and approval of printed packaging material sheet (PPMS)
- Tracking and documenting regulatory activities in respective tools, trackers and databases
- Compiling and submitting of maintenance submissions
- Managing printed text material according to the quality standards and timelines set by Swissmedic and other stakeholders as well as involving relevant global and local functions
- Communicating and tracking regulatory, relevant activities and commitments

START: 04/2017
DURATION: 6MM+
LOCATION: Canton Zug, Switzerland
REF.NR.: BH10466

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.

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