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Regulatory Affairs - Technical Regulatory Writer Belgium,  

Posted on : 20 April 2017

Project Description

Business LineConsulting ServicesJob DescriptionWe are looking for 2 Technical writers CMC for one of our clients based in Brabant Wallon. The technical Regulatory Writer is involved in the company's regulatory activities related to new and existing products, on domestic or international basis. Primary Tasks & Responsibilities: Writing CMC parts of regulatory variations Writing Module 2 of regulatory files derived from completed eCTD Modules 3 Writing IMPDs as far as CMC information is concerned Writing Responses to Questions raised by Regulatory Authorities on CMC matters Update of internal tracking system linked to their CMC activities Involvement in internal initiatives for improvement of processes/ ways of working ProfileEducation: Scientific university degree Hard Skills: Experience inwriting CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International Knowledge of regulatory procedures / systems / guidances Experience working with Biologics (if possible preferred over Pharmaceuticals) Knowledge of the EU/US variations policy Experience in a research laboratory or in regulatory/drug development/public health organization Soft skills : Manages own time to meet agreed short-term targets Ensures the coherence between contributions / quality of final results Team player ICT skills : Microsoft Office (Word, Excel, PowerPoint) What we offerYou will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues. Who we areKeyrus Biopharma, member of the international group Keyrus, is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including regulatory affairs, project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance and medical & scientific communication.CategoryRegulatory AffairsLocationBrabant WallonContact person Beverley Ebara


Brabant Wallon Belgium

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