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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



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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