Global Regulatory Labeling Lead

Takeda; Boston (MA); Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Global Regulatory Labeling Strategy in Massachusetts (Virtual) to lead global labeling strategy and content for multiple products. You will coordinate GLOC processes, author CCDSs/USPI/EU SmPCs, and align local labeling with CCDS while managing risks and negotiations with Health Authorities.

You will guide cross-functional teams across Clinical, Safety, Medical Affairs, and Regulatory to implement labeling plans that reflect new data, safety signals, and

Qualifications

• Bachelor’s degree in a scientific discipline required.
• Eight or more years in pharma with labeling experience; or five+ years in regulatory roles.
• Experience creating or updating CCDSs, USPIs, and EU SmPCs.
• Experience developing Target Labeling Profiles (TLPs).
• Strong knowledge of US and EU labeling requirements and guidelines.
• Ability to interpret scientific and regulatory data for labeling.

Responsibilities

• Lead cross-functional labeling teams, guiding global labeling strategy and content.
• Coordinate labeling approvals through GLOC with labeling and product leads.
• Prepare and align GLOC chairs and members for labeling reviews.
• Author and manage TLPs, CCDSs, USPIs, EU SmPCs and other labeling documents.
• Develop labeling implementation plans incorporating new data and authority feedback.
• Support end-to-end label development, submissions, and negotiations.
• Lead or support labeling negotiations with Health Authorities.
• Ensure compliance with regulatory requirements across regions.
• Align local labeling with CCDS and manage local exceptions.
• Identify labeling risks and propose mitigation strategies.

Skills

Global labeling strategy

Cross-functional leadership

US/EU labeling expertise

Project management

Regulatory writing

Stakeholder management

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MSc/PhD/PharmD) preferred

Job description

Takeda is seeking an Associate Director, Global Regulatory Labeling Strategy in Massachusetts (Virtual) to lead global labeling strategy and content for multiple products. You will coordinate GLOC processes, author CCDSs/USPI/EU SmPCs, and align local labeling with CCDS while managing risks and negotiations with Health Authorities.

You will guide cross-functional teams across Clinical, Safety, Medical Affairs, and Regulatory to implement labeling plans that reflect new data, safety signals, and