Description
Lead innovative regulatory strategies at Teva as a Regulatory Affairs Manager in Scarborough, Ontario. This hybrid role focuses on Canadian submissions and strategic planning for generics and combination products.
As the Regulatory Affairs Manager, you will spearhead Canadian regulatory efforts for generic medicines, including complex forms and drug-device combinations. You will provide regulatory guidance, oversee submissions to Health Canada, and collaborate with global teams to ensure timely launches. Your expertise in regulatory strategy and compliance will drive successful outcomes in a dynamic biopharmaceutical environment.
Key Responsibilities:
• Prepare and submit Abbreviated New Drug Submissions
• Manage product labeling updates and safety information
• Lead Canadian regulatory input in global projects
• Monitor Canadian regulations and assess impacts
• Communicate evolving Health Canada guidelines
Requirements:
• Bachelor’s in a science-related fiel...
As the Regulatory Affairs Manager, you will spearhead Canadian regulatory efforts for generic medicines, including complex forms and drug-device combinations. You will provide regulatory guidance, oversee submissions to Health Canada, and collaborate with global teams to ensure timely launches. Your expertise in regulatory strategy and compliance will drive successful outcomes in a dynamic biopharmaceutical environment.
Key Responsibilities:
• Prepare and submit Abbreviated New Drug Submissions
• Manage product labeling updates and safety information
• Lead Canadian regulatory input in global projects
• Monitor Canadian regulations and assess impacts
• Communicate evolving Health Canada guidelines
Requirements:
• Bachelor’s in a science-related fiel...
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