- Preparation of the documentation required for submission of the Clinical Trial Application and authorization procedures for placing on the national and centralized marketing;
- Checking printed medicines in order to Ensure the integrity and quality of labeling and of product information;
- Prepare the technical documentation on the occasion of changes AIC;
- Work with the Market Access for the regulatory aspects of the activities related to the launch of products on the market;
- Prepare / update the documentation in order to Ensure regulatory compliance;
- Rating change and their regulatory impact;
- Managing the documents.
- Experience of at least two years in the regulatory field, Gained in companies with production manufacturing sterile finished products;
- Knowledge of English Both written and spoken.