Job Description

Key Responsibilities:

• Leadership & Strategy:
• Lead cross-functional labeling teams, driving alignment on strategy and content.
• Provide strategic guidance to labelling leads and serve as a liaison between the labeling team and senior leadership.
• Mentor labeling leads and review implementation plans to ensure up-to-date, compliant information is provided.
• Labelling Document Management:
• Author and manage the creation of new/revised labeling documents (TLP, CCDS, USPI, EU SmPC) with input from relevant functional areas.
• Coordinate global labeling efforts to ensure timely submission and negotiations with Health Authorities.
• Stakeholder & Escalation Management:
• Manage relationships with Global Regulatory Leads and escalate issues when necessary, proposing risk mitigation strategies.
• Facilitate communication with cross-functional teams (clinical, safety, medical affairs, commercial) to ensure effective collaboration on labeling strategies.
• Regulatory Compliance & Precedent Analysis:
• Conduct precedent searches, analyze competitor labeling and trends, and develop competitive labeling strategies.
• Ensure alignment with global regulatory requirements and health authority expectations.
• Vendor & Process Management:
• Oversee external vendors managing labeling activities and drive continuous improvement of labeling processes.

Education & Competencies:

• BSc degree required; advanced scientific degree (MSc, PhD, PharmD) preferred.
• 10+ years of experience in the pharmaceutical industry, including 8+ years in labeling or 6+ years in regulatory affairs

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