Global Labeling Strategy Lead, Associate Director (Remote)

Takeda Pharmaceutical Co.; Agawam (MA); Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. in Cambridge, MA seeks a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies.

The role guides labeling development for US/EU regions, interfaces with Clinical, Pharmacovigilance, Legal, and Commercial teams, and shapes strategic labeling decisions across global programs. Candidates should have 7–10 years in biopharma labeling or regulatory strategy with deep knowledge of USPI, EU SmPC, and CCDS, and readiness to lead cross-functional teams in a

Qualifications

• Minimum of 7–10 years in the biopharmaceutical industry with emphasis on labeling or regulatory strategy.
• 5–7 years of direct experience in global US/EU labeling roles preferred.
• Detailed understanding of pharmaceutical drug and device labeling requirements.
• Experience with Core Data Sheets, USPI, and EU SmPC.
• Knowledge of SPL format and E2E labeling tracking systems.

Responsibilities

• Drives labeling strategy for the PDT BU including CCDS, US, and EU labels.
• Formulates and implements innovative regulatory strategies for labeling development.
• Leads CCDS, US, and EU Labeling Teams and cross-functional projects.
• Interprets clinical data to optimize labeling and support regulatory submissions.
• Provides guidance on regulatory labeling requirements and Health Authority guidance.

Skills

Regulatory strategy

Labeling expertise

Project management

Cross-functional leadership

Global experience

Strategic thinking

Communication

Decision making

Education

Bachelor’s degree or higher

Advanced scientific/health sciences degree

Job description

Takeda Pharmaceutical Co. in Cambridge, MA seeks a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies.

The role guides labeling development for US/EU regions, interfaces with Clinical, Pharmacovigilance, Legal, and Commercial teams, and shapes strategic labeling decisions across global programs. Candidates should have 7–10 years in biopharma labeling or regulatory strategy with deep knowledge of USPI, EU SmPC, and CCDS, and readiness to lead cross-functional teams in a