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Stagiaire en Recrutement - Consultance RH - Bruxelles/Gosselies/Mont-Saint-Guibert/ Saint-Georges-sur-Meuse

PaHRtners est une entreprise belge de consultance en Ressources Humaines (RH). Nos bureaux sont situés à Woluwe-Saint-Lambert (Bruxelles), à Gosselies, à Saint-Georges-sur-Meuse (Liège) et à Mont-Saint-Guibert (Wallonie).

Nous sommes notamment spécialisés dans le recrutement et la sélection de scientifiques, d’ingénieurs, d’experts et de top managers. Nous fournissons ces services principalement aux secteurs industriels et de la santé.

Les valeurs-clés sur lesquelles repose notre approche sont l’authenticité, la transparence et le respect. Consultez www.pahrtners.be ou contactez info@pahrtners.be pour plus d’info.

Pour renforcer l’équipe, nous recherchons actuellement un(e) :

Stagiaire en Recrutement

– pour 4 à 6 mois –

Tâches :

En tant que stagiaire, vous recevrez tout d’abord une solide formation. Sous la supervision du responsable de stage, vos principales tâches seront les suivantes :

  • Exploiter les outils modernes de recrutements : réseaux sociaux, bases de données, approche directe, cooptation, etc.
  • Rédiger et publier des annonces sur les sites Internet.
  • Participer au sourcing, screening et à la pré-sélection des profils identifiés.
  • Contacter les profils identifiés et assurer un suivi professionnel tout au long de la procédure.
  • Réaliser des prises de références professionnelles.
  • Participer aux entretiens de sélection, et débriefing.
  • Assister aux Assessment/Development Centers et analyser les compétences.
  • Assurer une bonne gestion administrative des dossiers de recrutement.
  • Réaliser des projets visant l’amélioration du service.
Profil :
  • Bachelor ou Master en RH, Psychologie, Business, Sciences ou Ingénieur.
  • Une réelle motivation à découvrir le monde du recrutement et de la chasse de têtes.
  • Un intérêt pour le monde industriel et scientifique.
  • Rigoureux(se), autonome et proactif(ve). Convivialité et curiosité intellectuelle.
  • Bonne communication en Français. L’anglais et le néerlandais sont des atouts.
  • Disposé(e) à vous rendre à Woluwe-Saint-Lambert ou à Gosselies par vous-même.
  • Aisance avec l’informatique et le web.
Offre :
  • Un stage de 4 à 6 mois en recrutement au sein d’une structure professionnelle.
  • Une solide formation reconnue dans le monde du recrutement.
  • Une réelle opportunité d’apprentissage et de réalisations concrètes.
  • Une opportunité de travailler sur des recrutements locaux et internationaux.
  • Un accompagnement individualisé et une autonomie grandissante.
  • Des horaires flexibles et modulables, une ambiance de travail ouverte et décontractée.
  • Un démarrage de stage selon vos préférences.

Other career opportunities

45 results

Medical Officer - Biotech, Biotechnology - Mont-Saint-Guibert

NOVADIP BIOSCIENCES (www.NOVADIP.com) is an innovative biotech company expert in the development of novel regenerative medicines. This human-sized structure is a leader in new generation therapies for hard & soft tissue reconstruction from autologous adipose stem cells.

NOVADIP BIOSCIENCES shows the ambition to grow to a worldwide class, with a successful closing of a 28M€ fund raising. Its main objective for the coming years is to develop its portfolio of products and to perform clinical validation and process industrialization of its main compounds.

NOVADIP BIOSCIENCES is a French/English-speaking work environment based in Mont-Saint-Guibert (close to University of Louvain-la-Neuve and Brussels area), Belgium, Europe.

In order to support our clinical development, we are actively looking for a (m/f):

Medical Officer

Responsibilities:

As a Medical Officer, you are part of the Medical Department consisting of the Chief Medical Officer, a Compliance Manager, 2 Clinical Project Managers, 2 Clinical Research Associates and a Clinical Research Assistant. You closely collaborate with them.

Your main responsibilities are as follows:

  • Design, contribute and write new study protocols and documentation related to clinical trials (IMPD/IND, investigator brochure, sponsor master files, patient informed consent, CRF, monitoring plan, safety plan /DSMB…) and contribute to the design of clinical development plans.
  • Develop and maintain a network of medical experts in the field and work in close collaboration with internal departments (i.e. R&D, Regulatory Affairs, Manufacturing, logistics…).
  • Identify, screen, select, initiate clinical sites, CROs, and other sub-contractors in the future trials in collaboration with clinical team.
  • Set up pharmacovigilance program (standalone or in collaboration with CRO).
  • Manage the interactions with ethics committees.
  • Monitor trials from a medical point of view, together with internal staff and clinical sites personnel.
  • Review incoming clinical data, and write medical reports or any other scientific files in collaboration with the Chief Medical Officer.
  • Facilitate communication flow between the clinical sites, CROs and Novadip.
  • Share your knowledge with the teams in order to overcome scientific, operational, regulatory, marketing, financial and strategic challenges within the company.
  • Active participation in training/coaching of operational teams involved in clinical trials (internal and external).
  • Report to the Chief Medical Officer.
Profile:
  • MD, PhD in Medical Sciences or Master in sciences or related field.
  • Min. 5 years of experience within either a CRO or a Pharma/Biotech/Medtech company. Experience in cell therapy is a great asset.
  • In depth understanding of clinical development plans, clinical trials, and superior knowledge of IHC-GCP.
  • Interest in basic sciences and translation of medical science in new clinical trials protocols.
  • Good communication skills with both clinical and non-clinical contacts.
  • Excellent attention to details and established organizational skills.
  • Demonstration of flexibility, professionalism, good interpersonal skills and managerial skills.
  • Fluency in written and spoken English is required. Good level of Dutch or French is desired.
  • Willingness and ability to be based in Belgium and to travel nationally and internationally.
  • To be in the possession of a full driving license.
Offer:

A diversified full-time permanent position within a high-potential innovative biotech company.

  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • Varied contacts inside the company and with the biotech/pharma sector.
  • An attractive salary package in line with the position responsibilities and your experience.

Responsable QHSE - Energie - Dunkerque

Dunkerque LNG (Dunkerque Liquefied Gaz Naturel) est une filiale à 65 % du groupe EDF SA, 25 % de l’opérateur belge Fluxys et 10 % de Total. L’exploitant du terminal méthanier de Dunkerque est Gaz-OPALE, filiale d’exploitation de Dunkerque LNG.

GAZ-OPALE est en charge de la conduite, de la maintenance et du respect des exigences HSE (Hygiène Sécurité et Environnement). Le terminal méthanier est un site ICPE (Installation Classée pour la Protection de l’Environnement) qui suit la directive SEVESO III seuil haut.

Responsable QHSE

Responsabilités :

En tant que Responsable QHSE, votre mission est de définir et coordonner la politique «qualité, hygiène, sécurité et environnement» de l’ensemble du terminal méthanier. Pour ce faire, vous pouvez compter sur une équipe de 2 personnes et sur un réseau de partenaires externes. Rapportant au Directeur d’Exploitation, vous faites partie du Comité de Direction de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Implémenter et coordonner le système de gestion de la sécurité : élaboration des plans d’urgence et mise en œuvre d’exercices.
  • Coordonner la sécurité du site, gérer et analyser les événements et incidents.
  • Évaluer et sensibiliser aux risques des postes de travail.
  • Participer au Comité d’Hygiène, de Sécurité et des Conditions de Travail (CHSCT).
  • Obtenir la triple certification Iso 9001, 14001, OHSAS 18001 par la mise en œuvre de documents contrôlés.
  • Garantir la mise en œuvre des évolutions réglementaires et assurer la gestion des déchets.
  • Veiller à la bonne application des règles d’accès au site.
  • Participer aux astreintes de la cellule de crise opérationnelle à raison d’une semaine sur cinq.
Profil :
  • Vous êtes titulaire d’un Bac+5 QHSE, scientifique, ou équivalent par expérience.
  • Vous possédez une expérience réussie de 5 à 10 ans en tant que Responsable QHSE d’un site industriel type SEVESO. Une première expérience en management est un plus.
  • Vous communiquez aisément en français et en anglais.
  • Vous êtes autonome, rigoureux(se) et faites preuve d’un esprit d’ouverture, d’écoute et de synthèse.
  • Vous appréciez le travail d’équipe et possédez une grande aisance relationnelle.
  • Vous êtes habitué(e) à travailler dans un environnement structuré et exigeant (ISO 9001-14001, OHSAS 18001).
  • Vous êtes basé(e) dans les environs de Dunkerque et êtes disposé(e) à vous déplacer ponctuellement en France et à l’étranger (Bruxelles, Zeebrugge, etc.)
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

Quality Systems Manager - Bio-Pharma/Biotech - South of Brussels

Our client is a fast-growing company that provides immunology-related analytical services to pharmaceutical and biotech companies internationally.

The company is located 50km South of Brussels. To strengthen the team, we are currently looking for a (m/f):

Quality Systems Manager

Responsibilities:

Reporting to the Quality Assurance Director, you are responsible for maintaining and enhancing the Quality Systems. You will oversee and manage Quality Assurance activities, ensuring GLP, GCP, GCLP, ISO/IEC 15189 Quality Processes, Training and Qualification.

Your main responsibilities are:

  • Develop, implement, maintain and enhance Quality Systems and associated procedures.
  • Participate in obtaining appropriate certification or accreditation.
  • Update and maintain Quality Assurance logs, databases, and generate metrics.
  • Provide GxP compliance, general QA support and guidance to personnel.
  • Conducts internal and external audits.
  • Develop, write and review SOPs to ensure compliance with applicable regulatory and corporate standards.
  • Participate in the development and delivery of internal training programs.
  • Review and evaluate investigations, findings and resolutions, change control, CAPAs, non-conformances, and audit observations.
  • Review CAPAs to determine effectiveness, perform trend analysis and compile summary reports.
  • Report compliance risks to senior management.
  • Support equipment and software validations.
Profile:
  • You hold a bachelor’s degree in Life Science, or equivalent through experience.
  • You have 5+ years of quality and/or compliance related experience in CRO industry, working in a regulated environment with direct QA responsibility.
  • You have excellent knowledge, understanding, and application of ISO/IEC 15189, GCP, EMA, OECD in relation to Good Laboratory Practice (GLP) and/or GCLP quality requirements;
  • You have good knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance, applied to various bioanalysis techniques.
  • You demonstrate documentation management skills, ability to design and implement quality processes;
  • You have a high level of attention to detail and accuracy, and excellent investigative techniques;
  • You have strong leadership, management and communication skills;
  • You are able to identify and/or resolve quality issues, discrepancies with others in a proactive, diplomatic, flexible and constructive manner;
  • You are able to independently convey information with authority, handle highly sensitive matters and interact with high-level contacts within other organizations.
Offer:
  • A full-time permanent position within a fast-growing company.
  • A dynamic, professional and stimulating work environment.
  • Training and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Ingénieur Commercial - Energie - Paris

Dunkerque LNG est en charge de l’exploitation et de la commercialisation du terminal méthanier de Dunkerque, deuxième plus grand terminal méthanier d’Europe continentale.

Fort d’un chiffre d’affaire annuel de 190€ millions, Dunkerque LNG est un atout majeur dans le développement de la stratégie d’approvisionnement en gaz du groupe EDF en raison de son raccordement unique à deux marchés de consommation : la France et la Belgique.

La société est composée d’une vingtaine de collaborateurs répartis sur les sites de Dunkerque et de Paris La Défense.

Afin de renforcer l’équipe commerciale de Dunkerque LNG à Paris, nous sommes activement à la recherche d’un (h/f) :

Ingénieur Commercial

Responsabilités :

En tant qu’Ingénieur Commercial, vous participez activement au développement du terminal tant d’un point de vue commercial qu’opérationnel. Rapportant au Directeur Commercial, vous êtes responsable de la relation commerciale avec les clients et les différents partenaires de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Entretenir et développer la relation commerciale avec les clients de Dunkerque LNG, EDF et Total.
  • Veiller au respect des contrats de réservation de capacité et de leur mise en œuvre opérationnelle.
  • Supporter la Direction Commerciale dans le pilotage de la relation contractuelle et/ou opérationnelle des prestataires : suivi du contrat de service, lancement et réception de nouveaux développements, etc.
  • Prospecter de nouveaux clients, notamment en participant à différents forums et salons industriels.
  • Planifier et gérer l’activité du terminal : bateaux, émission, stock, etc.
  • Rapporter de manière régulière la performance commerciale et opérationnelle du terminal.
  • Participer aux astreintes de soutien à raison d’une semaine sur quatre.
Profil :
  • Vous êtes titulaire d’un Bac+5 de type école de commerce, d’ingénieur ou universitaire.
  • Vous êtes fraichement diplômé(e) ou possédez une première expérience dans le secteur gazier.
  • Vous êtes orienté(e) clientèle, résultats et solutions, et doté(e) d’un très bon relationnel.
  • Vous êtes flexible, autonome, organisé(e), analytique et rigoureux(se).
  • Vous communiquez aisément en Français et en Anglais.
  • Vous êtes basé(e) à Paris La Défense et disposé(e) à vous déplacer de manière régulière à Dunkerque et ponctuellement à travers le monde.
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

Responsable Administratif et Financier - Belgian Brewery - Péruwelz

La Brasserie Caulier est une entreprise familiale de la région de Tournai, située à Péruwelz. La brasserie produit ses propres bières depuis près de 20 ans et jouit d’une excellente réputation dans le secteur.

L’équipe actuelle, composée de 17 passionnés, brasse des bières 100% naturelles, appliquant des méthodes de fabrication artisanales. La brasserie connaît une croissance importante depuis quelques années et vient d’entamer un vaste plan d’investissement qui lui permettra de doubler sa capacité de production.

Afin de soutenir la croissance de la Brasserie Caulier, nous sommes à la recherche d’un (h/f) :

Responsable Administratif et Financier

Responsabilités :

En tant que Responsable Administratif et Financier, vous faites partie de l’équipe de direction et êtes responsable des composantes administratives, financières et RH de la brasserie. Par votre intervention, vous facilitez la gestion opérationnelle de l’entreprise et la prise de décisions stratégiques.

Vous principales responsabilités sont les suivantes :

  • Mettre au point les budgets annuels avec le directeur général et veiller à leurs suivis.
  • Définir et mettre en place un système de contrôle de gestion efficace, notamment en améliorant l’implémentation et l’utilisation de Microsoft NAVISION.
  • Prendre en charge l’ensemble des démarches administratives, comptables et juridiques liées à la gestion de la brasserie.
  • Implémenter une gestion efficace des RH pour anticiper les besoins de l’organisation (recrutement, formations, politique salariale, établissement fiche de paie, etc.).
Profil :
  • Vous êtes titulaire d’un Master en économie, finance ou gestion.
  • Vous avez entre 2 et 8 années d’expérience, dont une première expérience en contrôle de gestion. Une expérience dans l’implémentation d’un ERP est un avantage.
  • Vous démontrez une passion pour la gestion d’entreprise et le monde brassicole.
  • Vous disposez de très grandes compétences analytiques et organisationnelles.
  • Vous démontrez d’excellentes aptitudes communicationnelles et relationnelles.
  • Vous travaillez aisément en équipe, et vous êtes force de persuasion.
  • Vous êtes reconnu(e) pour votre rigueur, votre autonomie, votre sens de la diplomatie et votre capacité à travailler par projet.
  • Vous êtes pragmatique, et orienté(e) résultats et solutions.
Offre :
  • Une fonction diversifiée comprenant de nombreuses responsabilités.
  • Des possibilités de formations, de développement et d’évolution de carrière.
  • L’opportunité de rejoindre une entreprise familiale et conviviale, et de contribuer à sa forte croissance.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil, à votre niveau d’expérience et au contexte.

Field Application Engineer - Green-Tech - Liège

SmartNodes is a Belgian innovative green-tech start-up active in the smart cities’ sustainable development.

Based in Liège, SmartNodes develops smart street lighting solutions based on high-tech controllers to power street lighting only in presence of road users.  The measurement of traffic density and user speeds is used for road mobility and safety applications.  By integrating environmental sensors, parking sensors, etc., SmartNodes’ public lighting network is becoming the driving force behind Smart City networks.  Please visit www.smartnodes.be.

SmartNodes’ customers are cities, regions and distribution network companies, worldwide.
In order to develop its business, we are actively looking for a (m/f):

Field Application Engineer

Responsibilities:

As a Field Application Engineer, you are the technical contact point for customers in both pre- and after-sales operations. You maintain close contact with customers in order to fixe their technical issues and to identify technical upgrade and commercial opportunities.

Your main responsibilities are:

  • You propose, with the support of the R&D organisation, the most suitable solution based on the customers’ specifications and expectations.
  • You support customers with technical trainings.
  • You closely follow-up and support customers during the installation phase and during evaluation periods on site.
  • You participate to international trade shows, exhibitions and events with technical demos and papers.
  • You write customer training and customer projects related notes.
  • You report work evolution on a regular basis.
Profile:
  • Bachelor or Master degree in engineering, electronics or IT, or equivalent through experience.
  • 0 to 3 years experience in the industry. Junior profiles applications are welcome.
  • Good communication skills and the will to fix technical issues with customers.
  • Self-motivated, hands on, results, rigorous and flexible.
  • Prone to travel around 50% of your work time.
  • Perfect command in spoken and written English and Dutch.
  • Knowledge in spoken French and German is an asset.
Offer:
  • A diversified technical customer support position in a fast growing start-up.
  • The opportunity to enter a sustainable development and green tech company.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package coherent with your experience.

Senior product engineer - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.

Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com. 

Miracor Medical offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Senior product engineer

Responsibilities:
  • You initiate and manage related projects.
  • You guide/manage risk management activities.
  • You create/review technical documentation and processes (as part of DHF, DMR, QMS).
  • You create verification and validation plans and coordinate their execution; apply statistical techniques in order to define samples sizes.
  • You organize and execute subjective evaluations (product reviews) to ensure all (product) requirements are met.
  • You review manufacturing documentation such as procedures/processes, BOMS and drawings.
  • You transfer and oversight of parts of manufacturing processes.
Profile:
  • Master’s degree in Engineering, Informational Systems or Computer Science.
  • 10+ years’ experience working in development of Class III (minimum IIb) medical devices (or other relevant regulated industry).
  • Ideally experience with hardware/software and catheters.
  • Experience in creating Risk Management plan, (Software) Hazard Analysis, DFMEA, PFMEA, Risk Management reporting.
  • Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards
  • In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
  • Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
  • Excellent organisational and communication (oral and written) skills.
  • Ability to work on teams as well as individually.
  • Fluent in English (oral and written).
Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Head of Regulatory Affairs - Biotechnology - Gosselies

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases affecting the central nervous system. The company is backed by strong international investors.

The company’s leading program is currently in an ongoing phase II/III clinical trial in EU and US, with results expected in 2020. In the upcoming months, our client is planning to launch a clinical trial for a second orphan indication. For more information about the company, please contact us via recruitment@pahrtners.be

Founded in Spain, the company is opening a subsidiary in Gosselies (Belgium). In order to strengthen the team in Belgium, we are currently looking for a (m/f):

Head of Regulatory Affairs

Responsibilities:

As a Head of Regulatory Affairs, you serve as a key and active member of the director leadership team, making sure regulatory objectives are met. You lead the organization on regulatory affairs, coordinate with regulatory advisors and mentors and provide training and interpretation of global regulatory requirements to all company personnel.

Your main responsibilities are:

  • Provide regulatory strategy and lead all regulatory interactions.
  • Author or co-author all regulatory documents (background documents, orphan designations, other) with appropriate support as needed.
  • Serve as liaison with EMA/CHMP.
  • Coordinate all FDA interactions with the support of US personnel (contractor or internal).
Profile:
  • Master’s degree in life sciences or equivalent through experience.
  • 10 years of experience in regulatory affairs within pharma/biotech industry.
  • Experience with both FDA & EMA.
  • Experience on processes such as ODD, fast track designation, PRIME, breakthrough and/or pediatric review priority voucher.
  • Experience in small molecules and orphan drugs is an asset.
  • Flexible, good time management, team-working skills, stress resistant, ability to work proactively and independently.
  • Well-developed communication skills, problem solving skills, creative thinking.
  • Fluent in English. A good command of French and/or Catalan is an asset.
  • Prepared to travel to Spanish site regularly.
Offer:
  • An interesting position within a high-potential clinical stage biotech company.
  • The opportunity to work in a human-sized and multicultural team environment.
  • A variety of interesting contacts with international exposure.
  • An attractive salary package in line with the position responsibilities and your experience.

 

Hardware Engineer - Green-Tech - Liège

SmartNodes is a Belgian innovative green-tech start-up active in the smart cities’ sustainable development.

Based in Liège, SmartNodes develops smart street lighting solutions based on high-tech controllers to power street lighting only in presence of road users.  The measurement of traffic density and user speeds is used for road mobility and safety applications.  By integrating environmental sensors, parking sensors, etc., SmartNodes’ public lighting network is becoming the driving force behind Smart City networks.  Please visit www.smartnodes.be.

SmartNodes’ customers are cities, regions and distribution network companies, worldwide.
In order to develop its business, we are actively looking for an (m/f):

Hardware Engineer

Responsibilities:

Reporting to the R&D Manager, you are developing hardware devices with sensor capabilities. You maintain close contact with Marketing in order to identify technical upgrade of current solutions and commercial opportunities.

Your main responsibilities are:

  • You propose, with the support of the R&D Manager, the roadmap of hardware devices with sensor capabilities.
  • You develop, maintain and upgrade SmartNodes sensors solutions.
  • You develop, maintain and upgrade hardware applications and/or you customize existing standard hardware to the most suitable solution based on the customers’ specifications and expectations.
  • You participate to demonstrations and hardware development projects.
  • Your report work evolution on a regular basis.
Profile:
  • Master degree in engineering, electronic or IT, or equivalent through experience.
  • 0 to 3 years experience in the industry. Junior profiles applications are welcome.
  • Good knowledge of sensors hardware concepts.
  • Good understanding of the algorithms used on the sensors.
  • Solutions, quality, innovation and results oriented, with good communication skills.
  • Self-motivated, team player, hands on, autonomous, rigorous and flexible.
  • Very good command in spoken and written English.
  • Good working knowledge in spoken French and Dutch.
Offer:
  • A diversified and challenging technical position within a dynamic team in a fast growing start-up.
  • The opportunity to enter a sustainable development and green tech company.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package coherent with your experience.

Head of RA - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please vist www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of RA

Responsibilities:

As a Head of RA, you lead and drive the execution of ASIT global regulatory and quality assurance strategy. Reporting to the CEO, you are responsible for regulatory affairs, quality assurance, and compliance activities across the company. You define and implement the quality and regulatory policies in line with applicable directives, guidelines and legal requirements.

Your main responsibilities are as follows:

  • Develop, propose and implement the company regulatory & quality strategy.
  • Manage regulatory documents submissions for clinical studies, and product approvals.
  • Implement an efficient quality system and a continuous improvement culture within the company.
  • Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and follow-up of
submissions.
  • Support and advise project teams on regulatory and quality issues.
  • Provide technical review of data and reports for regulatory submissions.
  • Draft product labelling, instruction leaflets and packaging.
  • Participate in internal/external audits, inspections and provide post-inspection
follow-up.
  • Write and update SOP, work instructions, and policies.
Profile:
  • Master or PhD in life sciences or equivalent through experience.
  • 10 years experience in a RA and/or a QA management position in the Biotech/Pharma sector.
  • Track record in developing quality systems from EU/US clinical developments to product approval.
  • Thorough knowledge of ICH guidelines, GxP and related regulatory guidances.
  • Proven track record of building strong relationships with internal and external stakeholders.
  • Ability to maintain multiple projects and meet timelines, including change management skills.
  • Client-centered and solution-oriented, with hands-on and pragmatic mindset.
  • Excellent leadership, communication and interpersonal skills.
  • Familiar with MS Office solutions.
  • Fluency in English.
Offer:
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.