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Phamaceutical Regulatory Affairs Manager France Suresnes France,
Posted on : 10 February 2017
LOCATION: Suresnes Permanent Contract ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes. As a result of the deployment of a new project we are now seeking a Regulatory Affairs Manager responsible for ensuring delivery of regulatory services by the RA Southern EU platform based in Suresnes. Primary Responsibilities Under the monitoring of the RA Platform Leader your missions are: Manage or supervise the compilation of regulatory files respecting national requirements (France/ EU). Obtain regulatory approvals. Provide regulatory advice to project teams to ensure the inclusion of regulatory concerns in relevant data planning and production to achieve the project objectives. Provide regulatory support to clients and associates. Liaising with regulatory authorities as required. To review the format and content of the texts related to packaging, summaries of product characteristics, labeling and records. Review the tasks, provide support and assist in charge of Regulatory Affairs and Regulatory affairs Assist Platform managers / or regulatory Hub consultants Senior Regulatory Affairs before sales Provide technical support before sales Ensure adequate technical description of the proposals and provide support for sales in costing Ensures that invoicing is correctly set. Validate invoices. Controls data entry of the Platform/Hub staff in PLG tools. Ensures KPI, metrics for all regulatory services supplied by the platform/the hub are adequately measured and reach or exceed defined targets Candidate profile: Education Master or higher graduate degree in a science related field Experience: 5 years minimum of professional experience required in a similar position in regulatory affairs and project management Key skills Expert in French /EU regulatory affairs registration and related fields Excellent organizational and interpersonal skills Ability to coordinate, lead and motivate a team You are fluent in English and/ or Portuguese and/ or Spanish (spoken and written) for daily contacts with local and internationally partners. Core competences Project management skills Rigorous and Pragmatic Customer- and Quality focus Result driven , accurate Problem solving capabilities Full training will be provided, and we encourage our staff to attend external courses as appropriate and to join professional organisations. There will be opportunities for advancement within the company or the wider group for motivated candidates, who have the ambition and potential for growth in our dynamic and international organisation. Benefits Competitive salary package Training and development International and growing company Dynamic environment Please email a Curriculum Vitae and cover letter to firstname.lastname@example.org.
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