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Regulatory Affairs Manager M/W - France  

Company managed [?] Still accepting applications

Posted on : 05 July 2017

Project Description

Company presentation :                           
  • Our company is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins.
  • Our company's insulin formulation portfolio, featuring four clinical-stage products and one preclinical product, is among the largest and most differentiated in the industry.
   

Job presentation :                           
Within a multidisciplinary team of 130 people, you will actively participate in product development whilst working in close collaboration with other members of the Research and Development team. 


The mission entails:
  • Participating in the development and implementation of regulatory strategy for the company's projects, 
  • Identifying and defining the regulatory issues regarding CMC as well as nonclinical and clinical development,
  • Interpreting the  regulations and providing and informing teams of regulatory guidelines, 
  • Advising and assisting the different departments on regulatory aspects, 
  • Drafting and/or revising various regulatory documents such as IMPD, IND and IB,
  • Managing the preparation of documents and answers to queries posed by health authorities,
  • Identifying the relevant regulatory experts and supervising their services, 
  • Monitor regulatory changes and developments on an international level, and anticipate future regulatory trends.                        


Profile :                           
  • With a higher education in a relevant scientific field (postgraduate level), the ideal candidate would have at least 5 years' experience in a similar role within the pharmaceutical industry, as well as the following skills: 
    • An excellent command of English, both written and oral, 
    • Excellent interpersonal skills and a flair for teamwork. 
  •  Passionate about Science and Innovation, you are motivated by an ambitious, competitive and promising environment. 
  • Our company promotes excellence in order to become a valuable partner to large pharmaceutical corporations specialized in the innovative treatment of chronic diseases.