Global Regulatory Labeling Director PDT & EU/US

The Fountain Group; Cambridge (MA); Hybrid; USD 186,000 - 192,000; Full time

Job summary

The Fountain Group in Cambridge, MA is seeking an Associate Director, Global RA Labeling Lead to direct global regulatory labeling strategy and lifecycle management for plasma-derived therapies (PDT), including CCDS, USPI, and EU SmPC, across US, EU and international markets.

You will lead global labeling teams, oversee submission-ready labeling, interpret clinical and safety data for compliant labeling, provide regulatory guidance on drug and device labeling, and manage end-to-end labeling

Qualifications

• Bachelor’s or Master’s degree required; advanced degree preferred.
• 7–10+ years in biopharma with 5–7+ years in global labeling.
• Experience with CCDS, USPI, EU SmPC labeling and regulatory strategy.

Responsibilities

• Lead global labeling strategy and lifecycle management for PDTs.
• Develop labeling strategies for development and marketed products globally.
• Direct labeling teams and cross-functional projects for submissions.
• Interpret clinical and regulatory data to support compliant labeling.
• Provide regulatory guidance on drug and device labeling requirements.
• Oversee labeling templates, version control, and QC processes.
• Support Health Authority communications and labeling negotiations.
• Deliver regulatory labeling training and ensure compliance.

Skills

Global regulatory labeling strategy

CCDS USPI EU SmPC development

Regulatory labeling lifecycle mgmt

US/EU labeling regulations

Regulatory submissions and negotiation

EDMS/document control

Cross-functional leadership

Team leadership

Health Authority guidance

Education

Bachelor’s degree

Master’s degree

7–10+ years biopharma labeling

5–7+ years global labeling experience

Job description

The Fountain Group in Cambridge, MA is seeking an Associate Director, Global RA Labeling Lead to direct global regulatory labeling strategy and lifecycle management for plasma-derived therapies (PDT), including CCDS, USPI, and EU SmPC, across US, EU and international markets.

You will lead global labeling teams, oversee submission-ready labeling, interpret clinical and safety data for compliant labeling, provide regulatory guidance on drug and device labeling, and manage end-to-end labeling