Regulatory Affairs Manager
il y a 1 semaine
RESPONSIBILITIES
:Guidance to some customers on the regulatory requirements
Writing, preparation of dossier for regulatory submissions like ANDA, Type B/C, BLA, Breakthrough Designation, Interact/fastrack,...
Writing and submission of the pre-IND and/or IND, in close collaboration with the customers and FDA.
Writing, submission, follow-up of Orphan Designation (ODD) requests to the FDA
Writing, submission, follow-up of briefing documents/interact meetings requests to FDA
Liaise and negotiate with global authorities or FDA authorities
REQUIREMENTS:
Master/PhD in Biology/Bio-Medical Sciences/Chemistry or Industry Pharmacist or Bioengineer.
Well-organized, flexible, rigorous, dedicated. Team spirit.
Fluency in English (oral, written). Any other languages are a plus.
Ideally a minimum 5 years in regulatory guidance and dossier writing in pre-marketing medicinal product development.
Very strong know-how of FDA requirement and legislation.
OUR OFFER:
We offer a long-term contract, a competitive salary package and the possibility of evolution in an international, dynamic, and fast-growing company.
Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now
-
Regulatory Affairs Expert
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for allThanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background,...
-
Regulatory Affairs Expert/specialist
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for allThanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background,...
-
Regulatory Affairs Expert/specialist/lead
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for allThanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background,...
-
Regulatory Affairs Expert/Specialist
il y a 1 semaine
Charleroi, Wallonie, Belgique Univercells Temps pleinRESPONSIBILITIES :Guidance to 2-3 customers on the regulatory requirements for approval of a first in human clinical study Writing of the IMPD and IB and submission of the clinical trial application packages in close collaboration with the customers and medicine agencies. Writing, submission, follow-up of Orphan Designation requests to the EMA and the...
-
Business Affairs Junior
il y a 1 semaine
Charleroi, Wallonie, Belgique Editions Dupuis SA Temps plein**Entreprise**Belvision est la société de production belge des Editions Dupuis qui produit principalement de l'animation, tant en 2D qu'en 3D, à la fois pour le cinéma et la télévision.Sa filmographie compte à la fois des séries TV telles que Cédric, Yakari, Boule et Bill, Petit Poilu, Kid Lucky mais également des longs métrages tels que La Tortue...
-
Business Affairs Junior/contrôle de Gestion
il y a 1 semaine
Charleroi, Wallonie, Belgique Editions Dupuis SA Temps plein**Entreprise**Belvision est la société de production belge des Editions Dupuis qui produit principalement de l'animation, tant en 2D qu'en 3D, à la fois pour le cinéma et la télévision.Sa filmographie compte à la fois des séries TV telles que Cédric, Yakari, Boule et Bill, Petit Poilu, Kid Lucky mais également des longs métrages tels que La Tortue...
-
Comptable (Interim en vue d'engagement)
il y a 1 semaine
Charleroi, Wallonie, Belgique EUMEDICA S.A. Temps pleinEumedica Pharmaceuticals is a leading international player in the pharmaceutical sector. We provide pharmaceutical companies with a wide range of customized services in various areas such as regulatory affairs, distribution, and promotion of pharmaceutical products, as well as personalized logistical services.We are based in Manage and we are on the lookout...
-
Responsable Affaires Reglementaires
il y a 1 semaine
Charleroi, Wallonie, Belgique Jobmatch Temps pleinAssumer l'entière responsabilité du processus de création de produits, y compris la nomenclature, en étroite collaboration avec toutes les parties concernées- Garant de l'exactitude des documents et textes relatifs aux produits (emballages), conformément à l'ensemble des réglementations applicables- Superviser la base de données des produits...
-
Project Manager
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: "...
-
Site/lab Manager
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinOUR ORGANIZATIONAt Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to...
-
Business Development Manager
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission:...
-
Product Marketing Manager
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission:...
-
Operations Support Specialist
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt _Univercells_, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for allThanks to a substantial knowledge of the pharmaceutical industry and a strong scientific...
-
project engineer
il y a 1 semaine
Charleroi, Wallonie, Belgique S&you Temps pleinLe groupe RH français Synergie compte 600 bureaux dans 15 pays différents. S&You est une division spécialisée dans le recrutement, la sélection et la recherche par approche directe de profils cadres ou expérimentés. Notre client est le leader européen des services multitechniques dans les domaines de l'énergie et des communications. Grâce à un...
-
Poject Engineer
il y a 1 semaine
Charleroi, Wallonie, Belgique S&you Temps pleinLe groupe RH français Synergie compte 600 bureaux dans 15 pays différents. S&You est une division spécialisée dans le recrutement, la sélection et la recherche par approche directe de profils cadres ou expérimentés. Notre client est le leader européen des services multitechniques dans les domaines de l'énergie et des communications. Grâce à un...
-
Head of Medical Writing
il y a 1 semaine
Charleroi, Wallonie, Belgique iTeos Therapeutics Temps pleinROLE: Head of Medical WritingOur Director, Head of Medical Writing will be responsible for building Medical Writing capabilities in support of multiple clinical programs across all phases of development, including late-phase Biologics License Application (BLA) activities. The successful candidate will also be capable of playing a 'hands-on' role in the...
-
Factory Quality Manager
il y a 1 semaine
Charleroi, Wallonie, Belgique HITACHI ENERGY BELGIUM Temps pleinDescription : Position Key Duties and Responsibilities: Assure quality of all products and services. Final authority to provide disposition of non-conforming material and product shipped to customers and received from suppliers. Assure compliance with all external and internal regulations, specifications and standard work. Implement, audit,...
-
Program Manager
il y a 1 semaine
Charleroi, Wallonie, Belgique Sabena Engineering Temps pleinJob category: Commercial Contract type: Permanent contract Site: Brussels & CharleroiSabena Engineering is a leading independent and international aviation solutions provider for civil and military operators. Our capabilities cover the main aircraft types, including Airbus, Boeing, Lockheed, regional and military aircraft and rotor aircraft. With our unique...
-
SAP Technical Expert
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission:...
-
Prevention Advisor Level 1 or 2
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinOur organizationAt Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to...