Sandra Mcgrath work email
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Sandra Mcgrath personal email
Sandra Mcgrath is a Director Regulatory Affairs at Novo Nordisk Canada Inc.. She possess expertise in regulatory submissions, clinical trials, ectd, regulatory requirements, diabetes and 10 more skills.
Novo Nordisk Canada Inc.
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DirectorNovo Nordisk Canada Inc. Feb 2017 - Present101 - 2476 Argentia Road, Mississauga, On L5N 6M1
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Manager Regulatory AffairsNovo Nordisk Canada Inc. Nov 1990 - Feb 2017Mississauga, OntarioResponsibilities include:Ensuring effective marketing applications (NDS, SNDS, Notifiable Changes) and Clinical Trial Applications in support of development products for serious chronic diseases. Determining which submission procedures to utilize and identifying issues, gaps, options, and mitigations for development plan to ensure optimal and timely submission and approvalInitiating and managing all interactions and relationships with Health Canada for all regulatory submissions. Leading the development of Canadian labels for new chronic disease treatments; understanding clinical study designs and their potential impact on product labels. Participating in review and approval of product advertising and promotional materials for compliance to Canadian requirements Key achievements:Submitted and received approval for NDS for Canada's first Human Glucagon Like Peptide-1 (GLP-1) which was the first full electronic New Drug Submission in Common Technical Document format for company. Coordinated team negotiations with Health Canada on product label. Contributed to launch preparations through marketing promotional reviews.2) obtained first approval in Canada for weight management indication for Human Glucagon Like Peptide-1 (GLP-1)
Sandra Mcgrath Skills
Sandra Mcgrath Education Details
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Medical Assistant -
Nelson High School
Frequently Asked Questions about Sandra Mcgrath
What company does Sandra Mcgrath work for?
Sandra Mcgrath works for Novo Nordisk Canada Inc.
What is Sandra Mcgrath's role at the current company?
Sandra Mcgrath's current role is Director Regulatory Affairs.
What is Sandra Mcgrath's email address?
Sandra Mcgrath's email address is sd****@****isk.com
What schools did Sandra Mcgrath attend?
Sandra Mcgrath attended Mcmaster University Centre For Continuing Education, Sheridan College, Nelson High School.
What skills is Sandra Mcgrath known for?
Sandra Mcgrath has skills like Regulatory Submissions, Clinical Trials, Ectd, Regulatory Requirements, Diabetes, Regulatory Affairs, Pharmacovigilance, Clinical Development, Sop, Drug Development, Pharmaceutical Industry, Cro.
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