Head of Regulatory Affairs (m/f/d).

Job ID: 11448

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Regulatory Affairs
Ihre Aufgaben
  • Responsibility and representation of the company for all issues in the area of admission as a member of the management team (report to the management)
  • Development and implementation of regulatory strategies
  • Coordination and preparation of new registration applications (EU, national) and processing of deficiency letters
  • Care and maintenance of existing approvals
  • Support and strategic consulting for international clients in the context of marketing authorization procedures and in the maintenance of existing marketing authorizations (Europe, Asia, South America)
  • Scientific Advice with authorities (Scientific Advice)
  • Preparation and review of pharmaceutical quality documentation
  • Review, interpretation and follow-up of legal requirements and guidelines
  • Management of the staff of the Admissions Department
  • Close cooperation with the development, quality control, manufacturing, quality assurance and business development departments as well as appropriate project coordination. Cooperation with external suppliers (e.g. active ingredient)
Ihr Anforderungsprofil
  • Natural scientists with several years of professional experience in drug regulatory affairs
  • Initial management experience
  • Extensive expertise in the European (incl. German) regulatory environment and experience with the relevant approval procedures (e.g. NTA, CTD, EMA, EU, ICH guidelines, European Pharmacopoeia; basic knowledge of GMP)
  • Independent, goal-oriented, cross-functional and structured way of working
  • Confident manner and very good written and spoken German and English skills
  • High level of commitment, initiative and enthusiasm