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International Regulatory Affairs Specialist

Global Responsibility:

Will be Responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of the Biotech products in international markets (including EU, MENA, LATAM, North Africa, Asia).Ensure timely registration of products in compliance with applicable regulation and guidelines.

Main Requirements:

  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
  • 5/6 years Regulatory experience and previous experience in registration of Biological products.
  • Thorough knowledge of registration procedures in EU (mainly centralized procedure) and desirable experience also in Latin America and Asia.
  • Knowledge of CMC, MAA is desirable.
  • Willing to travel, at least 25%.
  • Permanent contract.
  • Full time.
  • Vacancy Located in Madrid.