Description
Bionorica is hiring a Regulatory Quality Specialist to independently prepare and maintain regulatory quality documentation for national and international marketing authorization procedures, including CTD Module 2.3 and Module 3 and IMPD documentation. The role also handles authority inquiries, prepares and coordinates scientific position papers, evaluates development and quality data for regulatory suitability, assesses the feasibility of new product and development projects, and advises Pharmaceutical Development on regulatory requirements. Candidates need a natural-science university degree, pharmaceutical or analytical development experience, knowledge of pharmaceutical quality regulations, and strong German and English skills. The full-time position offers approximately EUR 5,537 to EUR 7,071 gross monthly salary.
