Sandra Mcgrath

Sandra Mcgrath Email and Phone Number

Director Regulatory Affairs @
Sandra Mcgrath's Location
Mississauga, Ontario, Canada, Canada
Sandra Mcgrath's Contact Details

Sandra Mcgrath work email

Sandra Mcgrath personal email

n/a
About Sandra Mcgrath

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.

Sandra Mcgrath's Current Company Details
Novo Nordisk Canada Inc.

Novo Nordisk Canada Inc.

Director Regulatory Affairs
Sandra Mcgrath Work Experience Details
  • Novo Nordisk Canada Inc.
    Director
    Novo Nordisk Canada Inc. Feb 2017 - Present
    101 - 2476 Argentia Road, Mississauga, On L5N 6M1
  • Novo Nordisk Canada Inc.
    Manager Regulatory Affairs
    Novo Nordisk Canada Inc. Nov 1990 - Feb 2017
    Mississauga, Ontario
    Responsibilities 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

Regulatory Submissions Clinical Trials Ectd Regulatory Requirements Diabetes Regulatory Affairs Pharmacovigilance Clinical Development Sop Drug Development Pharmaceutical Industry Cro Oncology Biotechnology Electronic Common Technical Document

Sandra Mcgrath Education Details

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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