30+ days ago
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 biotech’s 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.
ASIT biotech has a headcount of 25 staff members, located at its headquarters in Brussels and laboratory in Liège, Belgium.
The Head of Regulatory Affairs defines the product development regulatory strategy and ensures its implementation for a complete and efficient development of the ASIT biotech drug products. He/she defines the strategic and scientific content of the relevant sections of product specific documents submitted to regulatory agencies worldwide (eg. LAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensures that these documents meet high scientific standards and regulatory requirements. The Head of Regulatory Affairs provides robust regulatory advices to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory requirements (guidelines, recommendations and/or advices) received from agencies.
Reports directly to the Chief Executive Officer.
· Scientific degree in life sciences or pharmacy
· Minimum 10 years of experience in the field of Regulatory Affairs
· Solid knowledge of ICH guidelines, EU and US regulations required for Regulatory submissions and Good Clinical Practice (GCP) guidelines
· Experience of face to face meeting with Health Authorities
· Good people management and leadership
· Stress resistant
· Good ability to take responsibilities
· High accountability
· Good reporting skills
· Capable to summarize complex data
· Strong organizational and communication skills (oral and written)
· Analytic capacity, details minded, meticulous
· Solid writing and editorial skills
· Team player, strong interpersonal skills
· Able to work independently
· Demonstrated ability to deliver results with appropriate quality and according to timelines of the company
· Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
· Fluent in French & English, with excellent writing skills.