Associate Director, Global Labeling Lead

Takeda; Boston (MA); Remote; USD 153,000 - 242,000; Full time

Job summary

An established industry player is seeking an Associate Director, Global Labeling Lead to spearhead the development and implementation of labeling strategies for innovative therapies. This pivotal role involves leading cross-functional teams, ensuring compliance with US and EU regulations, and managing the labeling process from development to approval. The ideal candidate will have extensive experience in the pharmaceutical sector and a strong understanding of global labeling concepts. Join a dynamic team in a remote capacity, contributing to the advancement of groundbreaking therapies that improve patient outcomes.

Qualifications

• 8+ years in the pharmaceutical industry with regulatory experience.
• Strong knowledge of US and EU labeling requirements.

Responsibilities

• Lead cross-functional teams to develop labeling strategies.
• Coordinate with management for labeling approvals.
• Manage local labeling processes and engage with health authorities.

Skills

Regulatory Compliance

Labeling Strategy Development

Cross-Functional Team Leadership

Trend Analysis

Health Authority Negotiations

Education

BSc or BA in a scientific field

MSc, PhD, or PharmD

Job description

Join to apply for the Associate Director, Global Labeling Lead role at Takeda.

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

1. Lead cross-functional labeling teams to develop and align labeling strategies and content.
2. Coordinate with senior management and global teams to obtain labeling approvals.
3. Author and revise labeling documents (TLP, CCDS, USPI, EU SmPC) ensuring regulatory compliance.
4. Manage local labeling processes, including exceptions and deferrals.
5. Engage in labeling negotiations with health authorities and ensure documentation accuracy.
6. Oversee external vendors managing labeling activities.
7. Conduct trend analysis and develop strategies based on competitor and regulatory insights.
8. Support inspections and audits related to labeling processes.
9. 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.