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FSP - Regulatory Affairs Project Manager WHO
Parexel International Corporation
Poland, Remote
We are currently looking for a client dedicated Regulatory Affairs Program Manager - WHO .
In this role you will be responsible for RA System Implementation activities and Support WHO regulatory activities ( Preparation and submission activities ; Planning and tracking activities, Mapping; Archiving information; Following KPI and taking related action; Investigation and solving issue; Support on regulatory exception vaccine supply management; Support on WHO project; Drafting requested document; Leading meeting and sharing meeting minutes). You may also act as a RA contact database management support.
This role can be based in Poland, Romania, Hungary, Croatia or Lithuania - office or home based.
Key Responsibilities:
Upload in CARS / Vault communication traceability with WHO & UN agencies
Upload in easydoc of REVS (exception form for supply)
Update OPAL requests (adding submission date & approval)
Specific subjects Investigation (e.g. investigation on sharing platform)
Management support for RA database
Support to draft communication emails and PPTs
Will be involved more in the processes with WHO (formalize the annual report)
Supporting and handling WHO specific submissions and routine requests
Keeping working instructions up-to-date
Managing OPAL/Binocs
Monitoring the planning and timelines
Skills and Experience required for the role:
University degree
Good understanding of pharmaceutical business, drug development, and project management
3-5 years of experience in Regulatory Affairs
Data management and planning experience
Excellent administrative skills, attention to detail
Fluent in English
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Job posted: 2022-09-24