RA Compliance Expert Transition Team
That's XPE. For one of our clients we are looking for: RA Compliance Expert Transition Team Organisation description:
XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services. We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product. As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment. One consultant to manage regulatory activities and interaction with external collaborators.Job description:
Therefore it is very important that the candidate clearly understands the pharmaceutical business, has a knowledge of Regulatory Affairs as well as some technical background. The candidate needs to be hands-on, reactive, stress-resistant and able to work in a team. 1. CMC/Regulatory Affairs activities To liaise between the GRA organisation and Manufacturing Performance Unit on regulatory compliance matters including deviations and change controls. Be the Single Point of Contact (SPOC) for any topic related to regulatory affairs. Follow-up of MA (marketing authorisation) and of regulatory life-cycle activities on Nimenrix and Mencevax in Europe and Worldwide. Ensures that these licences for Nimenrix and Mencevax are maintained in compliance with regulatory requirements worldwide. Review and approval of all source documentation supporting CMC variations impacting Nimenrix and Mencevax. Efficient follow-up to respond to any questions and respect the timings of the projects. Maintain close contacts with the Local Operating Company's in the countries. Identify key issues on resource or registration activities that could prevent achieving objectives or that could lead to supply issues and pro-actively propose solutions to management to solve the problem. Coordinate questions & answers and commitments to external partner and to BOH (Boards of Health). Contribute to preparation and review of PQR (Product Quality Review). Coordinate the requests for market specific requirements. Note that this role does not include any CMC writing as this is done by the external partner. 2. Change Controls Initial assessment of potential regulatory impact of changes. Review and approval of eCCs impacting Nimenrix and Mencevax. Liaise with Operations for the definition of implementation and release strategy. Follow the submission, approval and implementation of changes and ensure alignment with internal and external partners to minimize the impact on supply continuity. 3. Key Interactions Participates in relevant internal and external meetings such as the Regulatory Project Team meetings, Implementation Committees, Technical Team meetings, etc. Be able to manage internally (between colleagues from different departments) as well as externally. 4. Operational To update in timely manner the regulatory tracking tool (OPAL) Send out weekly OPAL reports to all stakeholders Interaction with external partner on their regulatory tracking toolProfile:
Scientific/Engineering degree ( Chemist or biochemist) Excellent understanding & knowledge of regulatory procedures / systems / guidances eg. Opal, CTD section (Module 3) Fluent spoken and written English Be able to manage short term issues with long term activities in parallel. Ability to work in project teams in a multidisciplinary environment and a matricial organization Develop networking relationship across the company and external partner organisations Be able to lead and manage cross-functional projects Knowledge of regulatory procedures/systems/guidances - RA or site conformance, (Bio)pharma & cGMP, QA, Project management, Technical lifecycleOffer:
What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra-legal advantages! If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client. XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713