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Technical Regulatory Writer - Compliance Belgium,  


Posted on : 24 June 2017

Project Description

Business LineConsulting ServicesJob DescriptionWe are looking for a medior Technical Regulatory Writer for Compliance for one of our clients based in Walloon Brabant. Scope: The Technical compliance regulatory writer is involved in the company’s regulatory activities related to Compliance projects, on a domestic or international basis. Role and main tasks: Writing CMC parts of regulatory life cycle variations/supplement for all destinations Writing Module 2 of regulatory files derived from completed eCTD Modules 3 Writing Responses to Questions raised by Regulatory Authorities on CMC matters Support to transversal Regulatory CMC activities ProfileEducation: University level (Life Sciences background is preferred) Required skills: Knowledge: Knowledge of regulatory procedures / systems / guidances Knowledge of Qualification / Validation principles. Knowledge of Change Control process Knowledge of cGMP Knowledge of biological products and process equipment. Experience Experience is writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International Experience working with Biologics (if possible preferred over Pharmaceuticals) Skills Manages own time to meet agreed short-term targets. Ability to clearly identify prioties and manage multiple tasks Good communication skills Writing skills Analytical skills, creative and critical mind Team player 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 is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research. At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services. Keyrus Belgium Offices: Chée de Louvain 88 - Waterloo-Lasne Rue Emile Francqui, 1 - Mont-Saint-Guibert Nijverheidslaan 3, - Strombeeck Bever CategoryRegulatory AffairsLocationWalloon BrabantContact person Beverley Ebara

Locations

Walloon Brabant Belgium

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