Elguezabal Noelia
Senior Regulatory Affairs Associate at Parexel
Based in Madrid, Spain
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Seniority
Staff
Department
Science
Location
Madrid
Industry
Pharmaceutical Manufacturing
Company size
20K
Contact information
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e•••••••@parexel.com
Phone
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Background
About Elguezabal Noelia
I have over 15 years, experience in clinical trials, I started as CRA and since 2008 I have worked in the Start-up phase in different roles and companies. Working for PAREXEL during the last 5 years. Since 2016 with a role of Sr. Regulatory Lead Associate in PAREXEL Consulting, coordinating global EU submission of Clinical Trial Applications and Authorizations to the Competent Authorities. Coordinating projects as Regulatory Leader, overseeing submissions to the European agencies, meet timeliness, follow up of any query raised by the local teams, regulatory agencies or the Sponsor, and working hard to meet client expectations. Client facing: main point of contact information for regulatory strategy, regular meetings to discuss regulatory issues, Kick off Meeting. Discuss and assure that all the budget is included in the approved budget with the Project coordinator. Experience in clinical trials management, Phase I, Phase II, Phase Phase IV and observational studies.
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