Lead Executive – Labeling

About the role

The Lead Executive – Labeling will manage the preparation, compilation, and submission of labeling projects to Health Canada and other regulatory agencies. This role ensures that all documentation, artwork, and label approvals are completed accurately and on schedule.

Key responsibilities

• Prepare and compile all required forms and documents for Health Canada submissions.
• Submit projects via DocuBridge and create BLUE projects for commercial and non‑commercial workflows.
• Maintain the RA Tracker, RIMS records, CCR‑QMS, and LAMS‑BLUE project files.
• Generate Text Compare Reports to verify package inserts and use BLUE proof‑compare tools for label approval.
• Coordinate peer reviews, respond to reviewer comments, and ensure timely completion of training modules.
• Collaborate with the GTA team and other stakeholders to achieve project outcomes while adhering to safety and compliance policies.

Required profile

• Pharmacy degree (M.Pharm, B.Pharm) or equivalent.
• Basic knowledge of regulatory requirements for labeling submissions in US FDA, Health Canada, or other markets.
• Strong written communication and proofreading abilities.
• Attention to detail for packaging artwork and specifications.
• Self‑motivated, responsible, and able to take initiative.

Required skills

• DocuBridge
• BLUE label verification tool
• RIMS
• CCR‑QMS
• LAMS‑BLUE
• Text Compare reporting

What we offer

• Inclusive work environment with accommodations for disabilities.
• Opportunities for professional development through training, webinars, and meetings.
• Engagement in a global health company focused on affordable medicines.