Alessandro T.
Regulatory Affairs Senior Specialist @Baxter International Inc.
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WORK HISTORY
Regulatory Affairs Senior Specialist @Baxter International Inc.
As Global Regulatory Lead for the following activities: With direction, develop and execute regulatory project plans Identify and elevate key areas of regulatory risk Participate as an active team member and provide regulatory advice to project teams as required Respond to questions from regulatory authorities within strict timelines Compile and submit, in a timely manner, regulatory documents according to regulatory requirements Maintain and update existing regulatory authorizations Support regulatory activities relating to specific portfolio of products/projects Prepare, review, and approve labeling and SOP’s Represent or lead Regulatory Affairs in project teams Maintain regulatory files in a format consistent with requirements Maintain awareness of regulatory requirements; identify relevant requirements
EDUCATION
PCSnet
Attestato corso Microsoft Excel, Corso Microsoft Excel
MDG 24
Attestato di partecipazione
Seconda Università degli Studi di Napoli, Naples (Italy)
University Master's Degree in "Pharmacovigilance, Regulatory Affairs and Pharmacoepidemiology"
Università degli Studi di Napoli Federico II
Pharmacy degree
ABOUT ALESSANDRO T.
I am a reliable and meticulous professional, always available to perform tasks assigned…
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