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 Authoritiez.
Manage relationships with Global Regulatory Leads and escalate issues when necessary, proposing risk mitigation strategies.
Requirements:
10+ years of experience in the pharmaceutical industry, including 8+ years in labeling or 6+ years in regulatory affairs.
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.
Oversee external vendors managing labeling activities and drive continuous improvement of labeling processes.
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