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Phamaceutical Regulatory Affairs Manager France - France  

Company managed [?] Still accepting applications

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  
  

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