Global Regulatory Labeling Lead — Associate Director

USDM Life Sciences; Cambridge (MA); Hybrid; USD 158,000 - 179,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

USDM Life Sciences seeks a senior Global Labeling Lead to drive regulatory labeling strategy for plasma-derived therapies. You will lead CCDS, US and EU labeling efforts, coordinating with Clinical, Legal, and Commercial teams to ensure compliant and strategic labeling across markets.

The role requires 7–10 years in biopharma labeling, global regulatory experience, and strong leadership in cross-functional programs. Hybrid work in Cambridge, MA is offered.

Qualifications

• Experience in plasma-derived therapies or biologics preferred.
• 5–10 years in biopharma labeling or regulatory strategy.
• Global labeling experience in US/EU.
• Ability to lead diverse teams across regions.

Responsibilities

• Lead labeling strategy for PDT BU and CCDS US/EU labels.
• Develop and implement regulatory labeling strategies for drug-device products.
• Align labeling plans with Clinical, Pharmacovigilance, Legal, and Commercial teams.
• Oversee CCDS and regional labeling reviews through governance processes.
• Provide guidance on Health Authority requirements and regulatory submissions.

Skills

Regulatory labeling knowledge

Leadership

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in life sciences or related field

Tools

EDMS / labeling tracking systems

Job description

USDM Life Sciences seeks a senior Global Labeling Lead to drive regulatory labeling strategy for plasma-derived therapies. You will lead CCDS, US and EU labeling efforts, coordinating with Clinical, Legal, and Commercial teams to ensure compliant and strategic labeling across markets.

The role requires 7–10 years in biopharma labeling, global regulatory experience, and strong leadership in cross-functional programs. Hybrid work in Cambridge, MA is offered.