Bilingual (English/French) Talented, accomplished drug safety and regulatory affairs senior manager with over 9 years' experiences with a strong background in Global Regulatory Affairs and Drug Safety.
Demonstrated track record of exceeding expectations and delivering quality regulatory dossier throughout the product cycle from development to approval and beyond.
Extensive experience in product categories such as OTC Monograph drugs, OTC NDAs, Cosmetics, Medical device and Food Supplements with proficiencies in regulatory compliance and CMC.
|Skills||Experience||Total Years||Last Used|
|Documentum Document repository||Expert||9||2016|
|Web base for Product Life cycle mgt eCTDSubmission||Expert||5||2016|
|eCTD viewing database||Expert||5||2016|
|Registration Information Mgt. System||Expert||3||2016|
|Change Control Management system||Expert||9||2015|
|Windows, Adobe Acrobat||Expert||15||2016|
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