Regulatory Affairs Professional
UCBPharma - Brussel - Verenigde Staten
Prepare and deliver regulatory operational plans for allocated projects/products. Project manage quality regulatory submissions to agreed... project targets. Provide operational regulatory input and guidance in cross-functional teams. Work flexibly within and across regions to provide...
Commercial Cimzia Quality Assurance
UCBPharma - Waals Brabant - Verenigde Staten
Analytical management : Provide expert advice and support on operational and general QA activities to UCB teams working on key projects... for the further development of the Commercial Cimzia portfolio requiring a regulatory submission or update, and related to Cimzia analytical...
Global Pharmacovigilance Systems and Processes, Safety Project Manager
UCB Pharma - Eigenbrakel, Waals Brabant
and Pharmacovigilance (drug safety) at UCB. The main goal of this function is to develop and optimize the safety processes and safety system functionalities... of this function is to identify the new regulatory requirements and technology changes related to safety systems and assess their impact. The daily work...
UCB Pharma - Eigenbrakel, Waals Brabant
and Global Medical Affairs in assuring quality and compliance into the Pharmacovigilance activities related to the UCB Pharmacovigilance System... regulations and guidelines and UCB procedures. Major accountabilities - To develop and execute PVQA strategic plans for driving quality in areas...
Drug Safety SOP/Training Manager
UCB Pharma - Eigenbrakel, Waals Brabant
staff to enable them to fulfill their job responsibilities in accordance with our quality standards, Good Pharmacovigilance Practices (GVP...), ICH guidelines, SOPs, processes and applicable regulatory requirements. The Drug Safety SOP/Training Manager drives SOP lifecycle management and Training...
UCBPharma - Waals Brabant - Verenigde Staten
Affairs in assuring quality and compliance into the Pharmacovigilance activities related to the UCB Pharmacovigilance System. To provide direct... and UCB procedures. Major accountabilities: - To develop and execute PVQA strategic plans for driving quality in areas impacted by GVP...
Clinical Project Manager/Senior Clinical Project Manager
UCBPharma - Brussel - Verenigde Staten
the team to deliver the project within planned timelines and budget, and according to required standards of quality and compliance. Depending... Satellite Team. Ensure adequate participation, contribution and accountability of the study team members. Ensure quality and adherence to the...
UCBPharma - Waals Brabant - Verenigde Staten
to the whole UCB early pipeline. Major Accountabilities In a matrix team environment, ensure : Ensures the group undertakes quantitative... Proposes, develops and maintains specific operating procedures, working instructions and user guides for ensuring compliance and quality...
Head, Global Dossier Management & Publishing
UCBPharma - Brussel - Verenigde Staten
the delivery of timely, high quality submissions compliant with local regulatory requirements and internal requirements including global... departmental resources to projects as needed and according to company and Global Regulatory Affairs priorities to ensure on-time and high quality...
Senior/Principal Engineer Device Development
UCBPharma - Waals Brabant - Verenigde Staten
This role will be responsible for technically evaluating mechanical sub-systems of drug delivery technologies for UCB's NCE and NBE... externally to develop devices that will add value to UCB pipeline products The list of role accountabilities will include: Project managing the...