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  • Functie titel:

    Regulatory Affairs Project Manager

  • Sector:

  • Job ref:

    46763

  • Start datum:

    2021-10-18

Regulatory Affairs Project Manager 

The company

You will join one of the most innovative pharmaceutical companies in the world in the field of complex diseases which are difficult to treat. With joining them you would contribute to their dedicated goal to provide hope to patients and their families around the world. 

Description:

Your responsibility within this role will be managing regulatory activities and the EU regulatory strategy for products that are still under development and for the products on the market in the EU region. 

Responsibilities:
  • - being an advocate for European regulatory requirements and strategy
  • - providing regulatory expertise for the life cycle management of registered products
  • - coordination of project sub-teams with a goal of planning and implementing the strategy of European submissions 
  • - coordinating the preparation of, and contribute to writing and reviewing of regulatory documentation
  • -  ensure maintenance and compliance of regulatory activities
Requirements:
  • - at least 4 years of experience in RA at European level
  • - experience in Medical Affairs maintenance 
  • - good project and people management skills
  • - ability to work in a matrix organisation ability to work in multifunctional and multicultural teams 
  • - fluency in English 
Other information:

Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button.