Stephanie Anderson Email & Phone Number

My responsibilities include…

My responsibilities include…

- Managed the assessment and completion of CMC submissions within Canada, the United States, the European Union, and International Countries.- Strategized for the implementation of new Guidance Documents and licence updates. - Performed license conformance checks to verify submission content against current guidance.- Efficiently responded to a critical Clarifax affecting multiple products and assisted in the coordination of the response between several departments.- Compiled and assembled Yearly Biologic Product Reports, generated sections of Periodic Safety Update Reports, prepared renewal documents for International countries, and completed Notifiable Changes, Type I/II Variations and Changes Being Affected as appropriate.

• Created a new teaching assistant position with course coordinators to meet student needs.• Assisted students in learning course material by presenting it in an open, alternative way to the textbook, lecture, or lab.• Worked in a teaching team to run labs efficiently within time constraints.

• Managed the production of numerous government submissions while maintaining the submissions library and central filing.• Independently created a database for use in the submissions library, implementing a new method of controlling documents within CanReg.• Completed a marketing database with a comprehensive review of all CanReg client corporations.

• Assisted in the preparations for an ISO audit at a client company.• Assisted in the development of a client companies Standard Operating Procedures and the training of employees in ISO protocol. The client was successfully certified, as were their manufacturers with no non-conformities.• Created Standard Operating Procedures for CanReg Inc. and assisted in the training of CanReg employees.

Masters Of Science, Biochemistry And Physiology

Thesis Title: Functional characterization of a putative wound-induced p-coumaroyltyramine 3-hydroxylase from solanum tuberosum Nominated.

Post-Graduate Certificate, Regulatory Affairs

Activities and Societies: Humber student representative for CAPRA Assisted at the CanReg Inc. booth at the annual RAPS conference.

Bachelors Of Science, Honours Molecular Biology And Biotechnology

Activities and Societies: Assistant Science Section Editor for Imprint 2005 - 2006 Biology Undergraduate Society President 2005 - 2007