Responsible for collaborating with cross-functional teams to develop and maintain global labeling, ensuring compliance with regulations and guidance.
Supports preparation, review, and updates of CCDS, local labels, and artwork, providing strategic labeling advice.
Leads labeling teams for assigned compounds, aligning content with global strategies and regulatory requirements.
Evaluates risks, manages labeling documents, and supports submissions and inspections.
Analyzes competitor labels and trends to optimize content.
Ensures accuracy in reporting and maintains labeling systems.
Builds effective communication with stakeholders and contributes to process improvements.
Qualifications include 6-8 years of pharmaceutical labeling/regulatory experience, knowledge of labeling regulations, and strong project management skills.
Core competencies involve strategic thinking, collaboration, communication, and accountability. The role offers a competitive salary and comprehensive benefits.