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Regulatory Affairs Senior Specialist Woluwe-Saint-Lambert Belgium,  

Posted on : 01 December 2016

Project Description

In order to face the development of its activities, ASIT biotech is currently seeking a Regulatory Affair Senior Specialist to support of the Regulatory Affair activities of ASIT biotech in the development of new ASIT+TM technology based allergy immunotherapy products. Main responsibilities will include Coordinate, prepare and follow-up the submission of regulatory documents for national or international clinical studies. Prepare or maintain technical files as necessary to obtain and sustain product approvals. Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review Provide regulatory advice to project teams (compile key regulatory documentation, provide interpretive assistance) Participate to definition of regulatory strategy Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Draft product labelling, instruction leaflets and packaging. Participate in internal or external audits, inspections and provide post-inspection follow-up information as requested Write or update standard operating procedures, work instructions, and policies. Requirements and competencies Scientific degree in life sciences or pharmacy Minimum 5 years of experience in the field of Regulatory Affairs Solid knowledge of ICH guidelines, EU regulations required for Regulatory submissions and Good Clinical Practice (GCP) guidelines Strong organizational and communication skills (oral and written) Analytic capacity, attention to details, meticulous Solid writing and editorial skills Team player, strong interpersonal skills Able to work independently within your area of responsibilities Demonstrated ability to deliver results to the appropriate quality and timeline We offer To join a company with a very high growth potential, To integrate a very competent and motivated team, To collaborate to the development of innovative products in a very dynamic environment, Attractive salary and benefit package. Applicants should send their CV to: Mr A. Vicaire ( with reference to Regulatory Affair Specialist Application. About ASIT biotech ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotechs product pipeline entails two novel ASIT+ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+ platform is flexible and would be applicable across a range of allergies. gp-ASIT+TM, our product candidate for the treatment of grass pollen rhinitis consists of a mixture of natural allergen fragments obtained from a purified specific proteinic extract from Lolium perenne pollen. In contrast to the synthetized peptides, the natural peptides (70% of the fragments ranging from 1,000


Woluwe-Saint-Lambert, Brussels, Belgium

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