Mrudula Chavan
Senior Regulatory Affairs Associate at Intertek
Based in Canada
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Seniority
Staff
Department
Legal
Location
Canada
Industry
International Trade and Development
Company size
30K
Contact information
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m•••••••@intertek.com
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Background
About Mrudula Chavan
7+ years experience in regulatory/quality review and writing of dossiers for regulated markets like EU, USA & Canada. Knowledge & Skills- Have knowledge about submitting regulatory documents like IND, NDA/NDS & ANDA/ANDS in CTD format as per EMA//MHRA/USFDA/Health Canada guidelines- Good technical writing skills and the ability to review and critically evaluate quality documents - Ability to work on a number of different aspects of one project and evaluate and integrate work from a number of sources into the project- Experience with e-CTD software systems like Docubridge, Extedo eCTD Manager and eCTDXPress - Comprehensive Understanding of the drug approval process and regulatory strategies in the European Union, US & Canada
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