Global Labeling Strategy Director – Remote-Eligible

Vertex Pharmaceuticals Inc (US); United States; Remote; USD 186,000 - 278,000; Full time

Job summary

Vertex Pharmaceuticals Inc (US) seeks a Regulatory Labeling Director to lead global labeling strategy for one or more marketed products, overseeing CCDS, PI, PIL and IFU across major markets including US, EU, GB, and CA. The role requires strategic leadership in labeling governance, regulator negotiations, and lifecycle management with critical interactions with FDA, EMA, and other authorities.

The position emphasizes cross-functional leadership, deep regulatory expertise, and the ability to

Qualifications

• Experience leading labeling development and regulator negotiation activities for a new marketing application or major indication expansion.
• Strong ability to translate complex labeling concepts into clear messages for multiple stakeholders.
• Deep knowledge of global labeling requirements and lifecycle management (CCDS, PI, PIL, IFU).

Responsibilities

• Plan, develop and maintain global labeling for one or more Vertex products across major markets (US, EU, GB, CA).
• Lead Label Review Group (LRG) and Executive Label Review Group (ELRG) discussions and regulatory interactions.
• Advise stakeholders on regulatory labeling requirements and oversee health authority responses and inspections.
• Manage lifecycle updates and strategic labeling initiatives, including CCDS and regional labeling.
• Stay current on labeling governance, technology trends, and eLabeling initiatives.

Skills

Labeling strategy

Regulatory liaison

Global labeling

FDA knowledge

Cross-functional leadership

Negotiation

AI in labeling

Education

Bachelor’s degree

Job description

Vertex Pharmaceuticals Inc (US) seeks a Regulatory Labeling Director to lead global labeling strategy for one or more marketed products, overseeing CCDS, PI, PIL and IFU across major markets including US, EU, GB, and CA. The role requires strategic leadership in labeling governance, regulator negotiations, and lifecycle management with critical interactions with FDA, EMA, and other authorities.

The position emphasizes cross-functional leadership, deep regulatory expertise, and the ability to