Labeling Hub Manager: Regulatory Submissions Lead

Viatris; Toronto; On-site; CAD 110,000 - 140,000; Full time

Benefits offered by this job

Benefits

Job summary

Viatris, a global healthcare company, is seeking a Labelling Hub Manager to oversee new and revised product labeling for Health Canada submissions. The role involves coordinating cross-functional teams to ensure regulatory and commercial compliance, updating product labeling, and leading projects with high-quality output.

Strong expertise in regulatory submissions and TrackWise is essential. You will engage with internal departments and external partners to finalize labeling that meets

Qualifications

• Must have strong understanding of Health Canada drug product legislation and guidelines.
• Must have excellent project management skills and ability to manage several projects simultaneously.
• Proficient in TrackWise and D2; knowledge of Documentum is a plus.

Responsibilities

• Prepares new and revised labeling for New Drug Submissions and supports launch/rebranding labeling.
• Researches and drafts labeling documents; coordinates with departments and SMEs to ensure regulatory compliance.
• Reviews Company Core Data Sheets and updates Product Monograph labeling as needed.
• Interacts with multiple departments and external parties to ensure labeling meets regulatory, legal and commercial requirements.
• Leads labeling projects independently and handles special projects for Canadian Health Authority.

Skills

Project management

Regulatory submissions

Health Canada knowledge

TrackWise

D2

Microsoft Office

Communication skills

Education

Bachelor's degree

Tools

TrackWise

D2

Documentum

Job description

Viatris, a global healthcare company, is seeking a Labelling Hub Manager to oversee new and revised product labeling for Health Canada submissions. The role involves coordinating cross-functional teams to ensure regulatory and commercial compliance, updating product labeling, and leading projects with high-quality output.

Strong expertise in regulatory submissions and TrackWise is essential. You will engage with internal departments and external partners to finalize labeling that meets