Associate Director, Global Labeling Lead

18 Days Old

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A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible. This position offers a base pay range of $153,600.00/yr - $241,340.00/yr, depending on skills and experience. Your employment application process will be initiated upon clicking the “Apply” button, and all submitted information must be accurate and in accordance with Takeda’s Privacy Notice and Terms of Use.
Job Description About the role Takeda is a global R&D organization focused on delivering innovative therapies. As the Associate Director, Global Labeling Lead, you will develop and implement labeling content and strategy for multiple products at various development stages, including high complexity products, ensuring compliance and alignment across global teams.
Key Responsibilities
Lead cross-functional labeling teams to develop and align labeling strategies and content.
Coordinate with senior management and global teams to obtain labeling approvals.
Author and revise labeling documents (TLP, CCDS, USPI, EU SmPC) ensuring regulatory compliance.
Manage local labeling processes, including exceptions and deferrals.
Engage in labeling negotiations with health authorities and ensure documentation accuracy.
Oversee external vendors managing labeling activities.
Conduct trend analysis and develop strategies based on competitor and regulatory insights.
Support inspections and audits related to labeling processes.
Contribute to continuous improvement initiatives in labeling processes.
Minimum Requirements
BSc degree (preferred) or BA; advanced scientific degrees (MSc, PhD, PharmD) preferred.
8+ years in the pharmaceutical industry, with at least 6 years in labeling or related regulatory experience.
Strong knowledge of US and EU labeling requirements and regulations.
Experience in developing and revising product labels for regulatory submissions.
Understanding of global labeling concepts and health authority audit processes.
Additional Information This role is classified as remote, following Takeda’s Hybrid and Remote Work policy, based in Massachusetts.
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Location:
Boston, MA
Salary:
$150
Category:
Management And Consultancy

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