sprachenwechsel d 30x25

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

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