Proficiency Profile
Ruth S. Moghtader, PhD
Regulatory Affairs
Application and Submission Procedures
- Full scope of experience regarding planning, preparation and submission of national German applications for medicinal products
- Broad contact to relevant decision making responsibles within the German health authorities
- Full scope of experience with regard to planning, preparation and submission of applications for medicinal products to authorities within the European Union (MRP / DCP)
- Certification / registration of in-vitro diagnostica
Regulatory Advice
- Constant up-dates on regulatory requirements
- Provision of regulatory advice prior to acquisition of new products (due diligence activities)
- Coordination / advice regarding product sales
- Representation of companies at authorities and third parties regarding regulatory matters
- Recruitment / evaluation of contract partners (e.g. manufacturers, quality control labs, analytical development and test labs, contract research organisations)
- Integration work in the course of company mergers
Quality Assurance
- Assessment of compliance
- Harmonisation of regulatory and pharmaceutical requirements for medicinal products
- Conception of chemical-pharmaceutical tests for medicinal products
- Change of manufacturing sites
- Initiation of specific quality tests in cooperation with external laboratories
- Up-date of quality asssurance handbooks, including for TÜV-certified companies
- Improvement of deficiencies that were required during prolongation of TÜV-certification and relevant update of the quality assurance handbook
Management-Experience / Leadership Skills
- Development / build-up and (re-)organisation of department structures
- Recruitment of qualified staff
- Structure and implementation of new organisation systems
(such as documentation, archiving, reporting system) - Application of project management tools
Work languages
- German
- English
- Persian