Global Labeling Strategy Lead

Biopharma Careers; Toronto; On-site; CAD 176,000 - 245,000; Full time

Job summary

Sanofi, a leading biopharma company, seeks a Labeling Strategist in Toronto, ON. You will define and drive labeling strategy for CCDS, US, EU, and WHO documents, coordinating cross-functional teams through the end-to-end labeling process for development, LCM, and marketed products.

You will support global regulatory strategies, prepare labeling components for submission dossiers, and lead multi-disciplinary labeling working groups to achieve timely approvals and compliant labeling across

Qualifications

• Knowledge of labeling requirements (CCDS, EU, US) and regulatory submissions.
• Ability to lead labeling strategy and coordinate multi-disciplinary teams.
• Experience with global regulatory interactions and health authorities.

Responsibilities

• Define and lead labeling strategy for corporate labeling documents and patient leaflets.
• Coordinate labeling review and approval across the end-to-end process for submissions.
• Support global regulatory strategies and prepare labeling components for dossiers.
• Chair labeling working groups and present proposals to governance committees.
• Lead cross-functional teams and mentor juniors on CCDS, EU, and US guidance.

Skills

Labeling strategy

Regulatory strategy

Cross-functional leadership

Project management

Stakeholder negotiation

Education

Bachelor’s degree in Life Sciences

Physician/Pharmacist/Veterinarian background

Job description

Sanofi, a leading biopharma company, seeks a Labeling Strategist in Toronto, ON. You will define and drive labeling strategy for CCDS, US, EU, and WHO documents, coordinating cross-functional teams through the end-to-end labeling process for development, LCM, and marketed products.

You will support global regulatory strategies, prepare labeling components for submission dossiers, and lead multi-disciplinary labeling working groups to achieve timely approvals and compliant labeling across