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CMC Project Manager Suresnes France,  


Posted on : 20 February 2017

Project Description

LOCATION: Suresnes France Fixed term 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 CMC Project Manager to participate in the preparation and filing of AMM for pharmaceutical products: Ensure the launch and follow-up of the pharmaceutical development of several Fixed Dose Combination projects at subcontractors in France and abroad. Take charge of the coordination of the CMC activities and of the actors to ensure the deposit of the files abroad. Taking into account country specific requirements   Primary Responsibilities Support Project Directors for the preparation of the scientific documentation within the framework of the filing and submission of CMC regulatory documents ( Module 3 and Quality Overall Summary) The drug products concerned are fixed-dose combinations for which the candidate will have to manage and monitor the sub-contracted activities: Formulation studies, Analytical development, Stability studies, Preparation of the Module 3. The regulatory files will be submitted in Europe and worldwide.   Candidate Profile Education: Master or higher degree in Science related fields Experience: 2 years minimum of work experience as project manager in the pharmaceutical field   Key Skills Knowledge of the pharmaceutical development (formulation and/or analytical development) Knowledge of CMC regulatory writing is a plus. Develop positive contacts with the working environment Search permanently to optimize knowledge and skills You are fluent in English and French (spoken and written) for daily contacts with local and internationally partners.   Core Competences Knowledge in pharmaceutical development (analytical and / or galenic) Have knowledge of analytical techniques and/or manufacturing processes The candidate will have to work in autonomy, with several actors based worldwide, so the command of English is mandatory.   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 recruitment@productlife-group.com.

Locations

Suresnes France

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