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Job ID :
65979BR
Location :
Netherlands - Tilburg
:
Job Description

  • Responsible for preparing and filing of the complete registration dossier (CMC, clinical and non-clinical) in-line with current guidelines and regulations
  • Participate in project teams that are responsible for the development of new products; assure that development is performed in-line with current EU legislation and ICH guidelines
  • Accountable for regulatory support to customers and maintenance of MA’s of Patheon
  • Attend meetings and review and sign documents related to regulatory affairs
  • Collect regulatory information that could be interesting additions to the portfolio
  • Evaluate possibilities for new products based on regulatory information
  • Responsible for the bioequivalence study: set-up of study in-line with guidelines, preparation of IMPD/CTA, labeling of study samples and monitoring


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