This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Regulatory Affairs Associate (Regulatory publishing with Russian)

Parexel International Corporation

Bucharest, București, Romania

We are currently looking for a Regulatory Affairs Associate (Regulatory Publisher with Russian) who will have the following responsibilities:The publishing and quality control of Regulatory submissions (eCTD core package creation; eCTD baseline; eCTD lifecycle maintenance); focus on EAEU region (Russian speaking countries)Performs word formatting and familiar with MS Word pluginsProduces high-quality submission by publishing, quality review and delivery of submissions in paper, NeeS and electronic format. For paper submissions, creates cross-references, table of content, tab / slip-sheets, and volumes. For electronic submissions, performs bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines.Publishes Regulatory documents using Publishing software applications in the client specified environment according to internal processes and agreed-upon timeline.Takes accountability with different Regulatory submission contact points to ensure proper organization of a timely submission. 'Can do' attitude and a practical approach to problem solving.QualificationsThe ideal candidate will possess:Pharmacy or Life Sciences with or without postgraduate qualificationsKnowledge in ICH guidelines, Regulatory Documentation & Regulatory Submissions with experience in eCTD Publishing Proficiency in using PDF Plugins, MS Office, and Regulatory Publishing toolAbility to work within a team, communicate effectively across all levels, and excellent organizational skillsGood project management and technical skillsFluent Russian and English- is a must

Job posted: 2021-10-23

3