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CMC Project Manager - France  

Product Life Group (company)


Posted on : 20 February 2017

Project Description

About us:
  • 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  

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.  

  • Competitive salary package 
  • Training and development 
  • International and growing company 
  • Dynamic environment