top of page

Proficiency Profile

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 (such as 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

  • initiation of specific quality tests in cooperation with external laboratories

  • up-date of quality asssurance handbooks, including for TÜV-certified companies

  • Handling of deficiencies in the course of certificate renewals and implementation of updates into the QA 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 (Farsi)

bottom of page