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Regulatory Affairs Associate (MAA)
Parexel International Corporation
Bucharest, București, Romania
We are currently looking for a Regulatory Affairs Associate (Publisher) 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 plugins
• Produces 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.Qualifications• Pharmacy or Life Sciences with or without postgraduate qualifications
• Knowledge in ICH guidelines, Regulatory Documentation & Regulatory Submissions with experience in eCTD Publishing
• Proficiency in using PDF Plugins, MS Office and Regulatory Publishing tool
• Ability to work within a team, communicate effectively across all levels and excellent organizational skills
• Good project management and technical skills
• Fluent Russian and English
Job posted: 2020-07-18