Regulatory Affairs Officer / Noord Brabant
- 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 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.
- 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.
Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard|
3581 CW Utrecht
tel 030 231 7350
mobiel 06 50650550