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Dawn Mackinley

Regulatory Affairs Specialist
Regulatory Affairs
BioVectra
Canada

Biography

Obtained Bachelor of Science from the University of Guelph, Ontario; Masters courses from the Atlantic Veterinary College. Nine years of Regulatory Affairs experience working with Novartis, AstraZeneca, and Mallinckrodt. Worked as a Biotechnology Project Manager with the Atlantic Canada Opportunities Agency, University of Prince Edward Island and private industry. Extensive experience in formulating and implementation of regulatory strategy as well as monitoring of product files in development phase through to approved products for regulatory compliance. Comprehensive background facilitating submission of human and veterinary drug master filings/dossiers for approvals to various agencies in collaboration with partners, government agencies, and project teams; Provision of guidance to internal and external clients regarding regulatory requirements for a wide cross-section of pharmaceutical applications. Joined BioVectra Inc. in 2015 as Regulatory Affairs Associate. Obtained Bachelor of Science from the University of Guelph, Ontario; Masters courses from the Atlantic Veterinary College. Nine years of Regulatory Affairs experience working with Novartis, AstraZeneca, and Mallinckrodt. Worked as a Biotechnology Project Manager with the Atlantic Canada Opportunities Agency, University of Prince Edward Island and private industry. Extensive experience in formulating and implementation of regulatory strategy as well as monitoring of product files in development phase through to approved products for regulatory compliance. Comprehensive background facilitating submission of human and veterinary drug master filings/dossiers for approvals to various agencies in collaboration with partners, government agencies, and project teams; Provision of guidance to internal and external clients regarding regulatory requirements for a wide cross-section of pharmaceutical applications. Joined BioVectra Inc. in 2015 as Regulatory Affairs Associate.

Research Interest

Business Administration

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