Regulatory affairs assistant

Within the framework of the company’s development policy, define and monitor compliance with the product registration process to obtain market authorisations as quickly as possible and in the best possible conditions. Main Activities Steer...

Within the framework of the company’s development policy, define and monitor compliance with the product registration process to obtain market authorisations as quickly as possible and in the best possible conditions.

Main Activities

  • Steer development in terms of regulatory and technical requirements.
  • Compile Market Authorisation application files for new products to the standards required for registration: collect, organise and analyse all the available information (notably internal and external R&D reports), write memos and contribute to appraisals.
  • Ensure MAs are obtained by monitoring progress of the appraisal, preparing documentation and arguments to answer the questions raised by the administrations.
  • Provide monitoring and internal communication on changes in French and European regulations for all subjects relating to product registration.

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