Global Labeling Strategy Lead — Remote

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

Job summary

Takeda Pharmaceutical Co. seeks an Associate Director, Global Regulatory Labeling Strategy, to develop and implement labeling content for products across development stages.

You will lead cross-functional labeling teams and collaborate with global stakeholders to ensure scientifically accurate, compliant, and strategically aligned labeling. You will oversee TLPs, CCDSs, USPIs, and EU SmPCs, while coordinating with US/EU labeling operations and Health Authority interactions.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• An MSc, PhD, or PharmD is preferred.
• Experience creating or updating CCDSs, USPIs, and EU SmPCs.

Responsibilities

• Independently lead cross-functional labeling teams and align global labeling strategy.
• Coordinate labeling approval through GLOC with labeling/product leads.
• Prepare and align GLOC chairs and members for labeling reviews.
• Author and manage TLPs, CCDSs, USPIs, and EU SmPCs for assigned products.
• Develop labeling implementation plans incorporating new data and Health Authority feedback.
• Coordinate global labeling sub-functions to support end-to-end label development and submissions.
• Lead or support labeling negotiations with Health Authorities alongside Global Regulatory Lead.
• Interpret laws and guidance to ensure compliant labeling content and processes.

Skills

Cross-functional leadership

Project management

Regulatory interpretation

Negotiation

Communication skills

Attention to detail

Global labeling strategy

Education

Bachelor’s degree in a scientific discipline

Advanced scientific degree preferred (MSc/PhD/PharmD)

Job description

Takeda Pharmaceutical Co. seeks an Associate Director, Global Regulatory Labeling Strategy, to develop and implement labeling content for products across development stages.

You will lead cross-functional labeling teams and collaborate with global stakeholders to ensure scientifically accurate, compliant, and strategically aligned labeling. You will oversee TLPs, CCDSs, USPIs, and EU SmPCs, while coordinating with US/EU labeling operations and Health Authority interactions.