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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

#LI-REMOTE

Job posted: 2022-09-24

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