Reema Dsouza
Regulatory Affairs Manager @Alexion Pharmaceuticals, Inc.
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WORK HISTORY
Regulatory Affairs Manager @Alexion Pharmaceuticals, Inc.
Mississauga, ON, CA
EDUCATION
Indo German Training Centre
Post Graduate Programme in Business Administration (PGPBA)
University of Lancashire
BSc(Hons)
Seneca College
Postgraduate Certificate
University of Lancashire
MSc
St. Xavier's College
PG Dip.
ABOUT REEMA DSOUZA
An Experienced Regulatory Affairs professional with a demonstrated history of working in the pharmaceuticals industry. • Skilled in new drug applications, life cycle management, promotional material reviews, labeling review and updation/maintenance of regulatory database • Expert in communication and coordination across different divisions in the organisation leading to successful submissions of drug products and health supplements. • Experience of working in end to end trial management including site management and database management of clinical trials in the therapeutic areas of cardiology, diabetes, transplantation (renal and liver) and vaccines (pediatric) • Life Cycle Management of existing drug (25 products) and 15 dietary supplements portfolio for India, Nepal, Srilanka, Bangladesh, Myanmar and Maldives • Successfully collaborated with internal and external partners to update the package inserts for 25+ products • Experience of working on cross functional projects involving new product assessments (formula review), preparation of regulatory strategies and product launches • Skilled in software\'s including Outlook, MS Word, PowerPoint, Excel, RIMS (Regulatory Information management system), ZINC (Promotional Material Review), TRACKWISE (QMS), ELDORADO (SOP and Document management system), VEEVA • Strong analytical skills with ability to learn and follow new processes as and when required • Excellent in written and oral communication and coordination, interpersonal skills presentation, ability to work independently as and when required along with excellent time management skills
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