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GR
αποτελέσματα

Regulatory Affairs Officer (RAO) από την εταιρεία ZEINCRO

2 ημέρες για να κάνετε αίτηση
Πλήρης Απασχόληση
Αθήνα

Περιγραφή Θέσης

ZEINCRO, a leading Contract Research Organization which provides full range, high quality services to the pharmaceutical industry
currently is looking to recruit a:

Regulatory Affairs Officer (RAO)
to join our team in Athens

Purpose of the role: 
The mission of Regulatory Affairs Officer is to ensure the licensing, marketing and legal compliance of medicinal and related products. Working as part of our Regulatory Affairs team, you will be responsible for:
  • Keeping up to date with local and EU legislation, guidelines and practices
  • Preparing and submitting Marketing Authorization applications, variations, renewals, withdrawals and transfers of Marketing Authorizations 
  • Supporting in preparation and submission of answers to Deficiency Letters (DLs) of Health Authorities
  • Performing and reviewing translations of labelling documents and adapting local labelling documents to Company Core Data Sheets (CCDSs)
  • Reviewing of artworks and promotional material to ensure regulatory compliance
  • Supporting pricing and reimbursement activities
  • Supporting in the provision of regulatory intelligence 
  • Liaising closely with Health Authorities 
 
Required Skills & Knowledge:
  • University Degree in Life Sciences, a post graduate diploma in relevant field will be considered an asset
  • Previous experience of at least 2 years in the regulatory affairs field and proven understanding of local and EU regulatory requirements is required
  • Experience in writing Modules 2.3 and 3 of Common Technical Document (CTD) dossier and familiarity with the relevant EMA/ICH guidelines will be considered as a plus
  • Clear understanding of both legal and scientific matters
  • Capacity of evaluating data and information received from the client or from other departments and ability to cooperate efficiently with other departments
  • Ability to multi-task, prioritize, keep deadlines and operate promptly and efficiently under pressure in a demanding multinational environment
  • Goal and results' orientation
  • Attention to detail as well as analytical and problem-solving skills
  • Advanced communication skills, team orientation, ability to successfully convey messages
  • Excellent command of the Greek and English languages (both verbally and written) 
  • Very Good knowledge of MS Windows and MS Office 

Join us for a challenging career! 
The company offers a competitive remuneration package, as well as continuous development and career opportunities in an exciting, international and supporting working environment. At Zeincro your career will flourish, as we care about what you can be and how fast you can learn. 
If you are interested in this job opportunity please send your CV by clicking on Apply Button by the 24/05/2019.

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RAO

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