Regulatory Affairs Officer / Noord Brabant


De opdrachtgever

Healthcare bedrijf.

De omschrijving

  • 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 MAs of this company.
  • 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.

De eisen

  • Education in BSc level or higher;
  • Pharmacy, Chemistry or Health Science Graduate with a minimum of 5 years regulatory experience;
  • Knowledge of European national and MRP/DCP submissions;
  • Knowledge of GMP.
  • Fluent in English, and excellent communication skills.

De arbeidsvoorwaarden

Contactinformatie

Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard
Consultant Medical
Maliebaan 80
3581 CW Utrecht
tel 030 231 7350
mobiel 06 50650550

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