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15.04.2020

Global registration Specialist

Acino
Фармацевтика
  • Регион:Київ
Англійська (вільно)

Responsible to support all Global RA managers for all products under the responsibility of Acino to enable new submissions and maintenance worldwide with focus on non-EU countries in Middle East & North Africa (MENA), Africa, Latin America (LATAM) but also supporting submissions for reference marketing authorizations in the EU and in Switzerland

 

Required qualification:

  • High school, PTA, CTA, MTA, Bachelor degree or similar education
  • Experience in pharmaceutical industry especially in regulatory affairs area
  • Good planning and organizational skills, self-organizing
  • Good computer skills - Document Management Systems as well as MS Office applications esp. Word, Excel, Power Point
  • Able to work in an international and interdisciplinary environment
  • Team player and good communication skills
  • Target-oriented personality, able to work under pressure and on multiple tasks simultaneously
  • Languages: English, any further languages is of advantage

 

Job descriptions:

  • Support of Global RA managers in terms of preparation of new marketing authorization applications and variations worldwide (e.g. preparation of Module 1, compilation of application forms), responses to DLs
  • Organization of country-specific certificates including legalization (CPPs, CoAs, MLs, GMPs, etc.)
  • Organisation of registration samples
  • Uploading of documents and dossiers into Document Management System (Docubridge) and maintenance of internal regulatory information and tracking database, compilation of eCTD when necessary
  • Support creation and maintenance of printed packaging material (labelling, initiation of requests)
  • Support of preparation, organisation, and management of shipment of dossiers to Health Authorities or partners and distributors