ProductLife Group is the leading, proven and trusted Pan-European specialist-outsourcing-services provider for the regulatory, safety and quality functions of the life sciences and cosmetics industries.
Through the optimum deployment of people and intellectual assets, we enable clients to achieve greater R&D effectiveness, significant cost reduction in capital and revenue terms, and improved operational speed and efficiency — all of them at the highest level of quality. Those performance-enhancing improvements are delivered through a blend of the highest-calibre people performing the highest-quality services comprising in-sourcing, functional outsourcing, strategic business process outsourcing and consultancy based on deep domain expertise and thought leadership.
We have three main areas of intervention: 1. Regulatory Affairs and Operations 2. Pharmacovigilance and Safety 3. Pharmaceutical Development & Quality See also www.productlifegroup.com
To support our double-digit growth in Belgium we are looking for motivated colleagues, eager to learn, keen to work client-facing, and who have the ambition and potential for growth in our dynamic and international organization. As Head of our practice Publishing services dedicated to the assembly and in compliance of regulatory affairs projects (submissions records, registration of pharmaceuticals) make sure the planning, organization and management of the service and teams to provide high quality services (time and budget) By contributing to the definition of offers in cooperation with the HoP you manage your teams and plan human resource needs in terms of projects and customer needs.
In this position your missions are supervise: The individual performance management of staff Reg Ops The training of teams on tools as ongoing projects The animation teams to achieve the required objectives Capacity development and process your service. Compliance with the requirements of regulatory and legal quality The day to maintain continuous improvement processes Delivery of your service Check and ensure the proper conduct of: electronic Managements assembling, compiling and publishing regulatory submissions records electronically links with the authorities to ensure in the allotted time compiling documents for submissions. Real support on the eCTD tools and eDMS with qualifying services and the application of best practices scan, if necessary you support your teams in updating and communicating changes within SOP and you: Make sure the correction of the size or architecture errors identified by the comprehensive case management for integration in bids Train users to ensure that documents are created, reviewed and approved in accordance with the SOP
profile: Bac + 3/4 in the document processing management you have a minimum of 4 years experience in regulatory affairs sector with a first proven experience in team management. You used to work in a multidisciplinary team and have great organizational skills. Perfect knowledge of Office package (Word, Excel, Power Point, Outlook, eCTD Manager, CTD, Nees ...). Peremptory command of English (oral and written) as daily contacts with people abroad. Envoyez votre lettre de motivation CV et références à recrutement@productlife-group.com