Спеціаліст з реєстрації лікарських засобів (Global RA Associate)

Main responsibilities:

• Support regulatory submissions (new registrations and life cycle management) of Acino portfolio products in countries and markets within the assigned international region(s) under supervision of Manager/GRA Lead (Regions of focus: Middle-East and Asia, North Africa, French Africa, Central English Africa and Mauritius, Central Latin America, CIS, potential territory extension)
• Support to partners in the region(s) in regards of preparations of responses to DLs and supporting additional materials
• Handling and coordination of legalization processes for RA documents, etc
• Active support to Labelling processes and updates to packaging material according to Corporate procedure and in compliance with local legislation
• Coordination of timely and relevant communication with regions regarding proposed /planned variations of drug product, support in submission planning and dispatch, monitoring of approvals
• Working with Corporate systems and databases, archiving and reporting

  Requirements to the candidate:

• High school, PTA, CTA, MTA, Bachelor degree, preferably in Pharmacy, Chemistry, Biology or another life science, or several years of working experience in pharmaceutical area preferably in regulatory affairs. International experience is a benefit
• Good knowledge of product life cycle, various international regulatory requirements and the registration procedures as well as understanding of the drug development, production process, pharmacovigilance and quality assurance topics
• Fluent in writing and negotiation in English. Know-how in further languages is of advantage
• Computer literacy (MS-office tools), good understanding of RA procedures and databases (experience in portfolio tracking systems, document management systems like docuBridge, Extedo, etc. and other RA tools will be an advantage)
• Good analytical, organizational and self-management skills
• Good communication, negotiation and interpersonal capabilities
• Ability to work cross-functionally and in international environment
• Target-oriented personality, able to work on multiple tasks/projects simultaneously