Global Regulatory Labeling Strategy Director

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda in Massachusetts seeks a Director, Global Regulatory Labeling Strategy to develop and implement labeling content for multiple products across development stages, including CCDS, USPI and EU SmPC. You will lead labeling cross-functional teams and coordinate with senior management to align strategy.

The role requires extensive experience in US/EU labeling, strong project management, and the ability to influence across functions, affiliates, and health authorities, with remote work options

Qualifications

• BSc degree, BA accepted; advanced degree preferred.
• 10+ years pharmaceutical industry experience.
• 8 years labeling experience or combination of 6+ years regulatory and/or related experience.

Responsibilities

• Lead labeling cross-functional teams and drive strategy alignment.
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• Coordinate with senior management and GLOC for labeling approvals.
• Independently author and manage CCDS, USPI and EU SmPC labeling updates.

Skills

Strategic thinking

Analytical skills

Leadership

Project management

Regulatory affairs

Education

BSc degree

Advanced degree (MSc/PhD/PharmD) preferred

Job description

Takeda in Massachusetts seeks a Director, Global Regulatory Labeling Strategy to develop and implement labeling content for multiple products across development stages, including CCDS, USPI and EU SmPC. You will lead labeling cross-functional teams and coordinate with senior management to align strategy.

The role requires extensive experience in US/EU labeling, strong project management, and the ability to influence across functions, affiliates, and health authorities, with remote work options