CMC Project Manager - France
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- Our company 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.
- Our company’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
- 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.
- Education: Master or higher degree in Science related fields
- Experience: 2 years minimum of work experience as project manager in the pharmaceutical field
- 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.
- 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.
- Competitive salary package
- Training and development
- International and growing company
- Dynamic environment