Remote Global Labeling Strategy Director

Regulatory Jobs; Massachusetts; Remote; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director, Global Regulatory Labeling Strategy to lead labeling content development and strategy for multiple products across development stages. You will manage cross-functional teams, coordinate with senior leadership, and drive timely submissions for USPI, CCDS and EU SmPC with a focus on compliant, up-to-date labeling.

You will collaborate with clinical, safety, medical affairs and commercial teams, oversee global labeling implementations, and liaise with health

Qualifications

• BSc degree required or preferred; BA accepted.
• Advanced scientific degree (MSc, PhD, PharmD) preferred.
• 10+ years in pharma with labeling/regulatory experience.
• Experience leading global labeling initiatives and cross-functional programs.

Responsibilities

• Lead labeling strategy and content across products at various development stages.
• Coordinate with GLOC and senior management for labeling approvals.
• Author and manage TLP, CCDS, USPI and EU SmPC submissions.
• Manage local labeling alignment and exceptions.
• Oversee labeling negotiations with health authorities and vendors.

Skills

Leadership

Cross-functional

Regulatory labeling

Project management

Education

BSc degree, preferred; BA accepted.

Advanced scientific degree (MSc, PhD, or PharmD) preferred.

Job description

Takeda is seeking a Director, Global Regulatory Labeling Strategy to lead labeling content development and strategy for multiple products across development stages. You will manage cross-functional teams, coordinate with senior leadership, and drive timely submissions for USPI, CCDS and EU SmPC with a focus on compliant, up-to-date labeling.

You will collaborate with clinical, safety, medical affairs and commercial teams, oversee global labeling implementations, and liaise with health