Regulatory Affairs Manager

Barrington James Limited

Später bewerben

We're looking for a candidate to fill this position in an exciting company.

  • Life cycle management
  • Renewal procedure for approved products
  • Dossier responsibility and preparation of modules 1-5, partly in cooperation with internal / external functions
  • Processing of notice of defects and fulfillment of requirements, including the coordination of internal or external specialist functions if necessary
  • Creation and coordination of texts (FI / GI / labeling) for new registrations, changes and extensions
  • Monitoring the regulatory and legal environment
  • Contacts with authorities, especially for the commercial area
  • Creation / review / modification of basic texts, red and yellow lists for the commercial area
  • Revision and possibly new creation of SOPs
  • PSUR requirement, support for specialist functions in the creation, monitoring of PSUR appointments as well as dispatch and documentation

  • Successfully completed scientific studies, preferably e.g. pharmacy or biology with a regulatory affairs postgraduate course

  • First professional experience in the approval of medicinal products is desirable

  • Very good knowledge of the specific rules and regulations of the pharmaceutical or chemical industry
  • Very good spoken and written English and German skills

Später bewerben

Stellenangebot in: Hamburg