BrightOwl Loader Loading

Phamaceutical Regulatory Affairs Manager France Suresnes France,  

Product Life Group (company)

Posted on : 10 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 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. 

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  

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


Suresnes France

Find a Job Find Candidates

Similar Jobs

More jobs from Product Life Group

Other jobs in France

Other jobs in Suresnes

Other jobs from Product Life Group in Suresnes

Other similar job in Suresnes

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like