Global Regulatory Labeling Strategy Lead

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Global Regulatory Labeling Strategy, to drive labeling strategy and content across products. You will lead cross-functional teams, align with global stakeholders, and ensure regulatory-compliant labeling (TLPs, CCDSs, USPI, EU SmPCs).

The role requires leading global labeling efforts, negotiating with Health Authorities, and coordinating with US/EU operations to deliver timely label development while integrating new scientific data.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• An advanced scientific degree (MSc, PhD, or PharmD) is preferred.
• Eight or more years in pharma with labeling or regulatory experience.
• Experience creating/revising global labeling (CCDSs, USPI, EU SmPCs).
• Experience developing Target Labeling Profiles with limited supervision.
• Strong knowledge of US/EU labeling requirements and teamwork in a global matrix.

Responsibilities

• Independently lead cross-functional labeling teams and drive global labeling strategy.
• Coordinate labeling approvals through the Global Labeling Oversight Committee (GLOC).
• Prepare and align GLOC chairs and members for labeling reviews and decisions.
• Author and manage TLPs, CCDSs, USPI, 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 with the Global Regulatory Lead.
• Interpret laws and guidance to ensure compliant labeling content and processes.

Skills

Labeling strategy leadership

Cross-functional collaboration

Regulatory documentation

Project management

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MSc/PhD/PharmD)

Job description

Takeda is seeking an Associate Director, Global Regulatory Labeling Strategy, to drive labeling strategy and content across products. You will lead cross-functional teams, align with global stakeholders, and ensure regulatory-compliant labeling (TLPs, CCDSs, USPI, EU SmPCs).

The role requires leading global labeling efforts, negotiating with Health Authorities, and coordinating with US/EU operations to deliver timely label development while integrating new scientific data.