Head of Regulatory Affairs

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. 

Further information can be found at: www.asitbiotech.com.

Job Purpose

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.

Key Responsibilities

  • 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 all along the development phase and the lifetime of the product.
  • Participate to product-related discussions and provides in-depth strategic, scientific and RA input, for technical aspects, for clinical/labelling/Non-Clinical or procedural aspects of given project.
  • Provide critical review for technical, for clinical/labelling/non-clinical or procedural regulatory documents, Global Regulatory Plans and Key Message Summaries.
  • 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
  • Facilitate and deliver the regulatory strategy to support the lifecycle of the productss for technical, for clinical/labelling/non-clinical or procedural aspects
  • Write or update standard operating procedures, work instructions, and policies related to RA.
  • Is responsible for Regulatory Intelligence
  • Develop and motivate collaborators within RA team and coordinate with multidisciplinary teams to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
  • Ensure planning and proper organization of activities in line with the company milestones.

Qualifications

·       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.

  • A full time position, permanent contract
  • A remuneration that will be in line with the industry standards + additional benefits
  • An innovative leading company, which could enable you to explore interesting career opportunities
  • A multicultural work environment in which competence and quality play an important role