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Administracja biurowa » Pracownik biurowy

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Regulatory Affairs Specialist/Writer - Combination Products - Zürich, Nr ref.: /JOBS.pl As the Regulatory Affairs Specialist/Regulatory Writer you will be involved with the writing of Pharmaceutical based MAAs and CTAs. If you are looking for an exciting forward thinking company, where you can put your expertise in managing the eCTD and writing MAAs and CTAs and be instrumental in driving forward the mission to improve peoples lives, then this is the job for you! Role responsibilities Responsibility for writing and updating Module 2 of the CTD in collaboration with internal stakeholders. With the Regulatory Affairs Manager be the point of contact for questions raised by notified bodies and health authorities following submission of CTAs. Ensuring that all data submitted is consistent with raw data provided. Your profile You should have at least 3 years experience working within the Regulatory function of an EU based Medical Device Company ideally working on combination products. Thorough knowledge of the relevant regulatory regulations and ICH Guidelines. Fluent in spoken and written English is a must, any additional language an advantage (German, French or Italian) You should be educated to at least degree level in Life Sciences or a related subject. Must have strong written and verbal communication skills and have experience working on cross-functional project teams. For more information or a confidential discussion about this position please contact Darren Hall either by telephone on or email me on Darren.Hall TECGroup.net including a copy of your CV in English and supporting documents. Due to the volume of applications for this position if you have not received a response within 5 working days then unfortunately on this occasion you have not been successful but we will consider you for other positions that may be suitable. Keywords: Regulatory Affairs, Reg Affairs, French, German, Switzerland, class III, Class 3, medical device, FDA, CE, vigilance, compliance. REG AFFAIRS, Medical Devices, REG AFFAIRS, Regulatory Affairs Specialist, RA Specialist , RA Specialist, Medical Devices, REG AFFAIRS, Regulatory Affairs Specialist, RA Specialist , RA Specialist, Medical Devices, REG AFFAIRS, Regulatory Affairs Specialist, RA Specialist , RA Specialist, Medical Devices, REG AFFAIRS, Regulatory Affairs Specialist, RA Specialist , RA Specialist, Medical Devices, REG AFFAIRS Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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