Global registration Specialist

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