Contract Regulatory Affairs Labeling Manager – Safety

Us Tech Solutions; Deerfield (IL); On-site; USD 61,000 - 63,000; Full time

Job summary

US Tech Solutions is seeking a Regulatory Labeling Lead to provide strategic oversight of safety labeling variations for regulated pharmaceutical products, ensuring regulatory compliance and patient safety across global markets.

The role interfaces with PV, Regulatory Affairs Labeling, and Global Labeling Operations to establish robust labeling processes including CCDS variations, PRAC triggers, and monitoring of innovator and generic labels.

Qualifications

• Bachelor’s degree or country equivalent in a scientific discipline.
• Masters and/or PhD will be an advantage.
• Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.

Responsibilities

• Key interface between PV, Regulatory Affairs Labeling Team and Global Labeling Operations
• Ownership and Establishment of Safety Labeling Processes for GRA including CCDS variations
• Oversee generic labeling surveillance and innovator-label monitoring
• Lead continuous improvement and KPI reporting including CCDS metrics
• Safety labeling governance and compliance oversight of safety related labeling changes across global markets
• Develop Training Materials for improved safety variation submission process
• System Owner for Fluxguard and CCDS/Safety Labeling Tracking
• Support PV and RA inspections as it relates to safety labeling

Skills

Regulatory knowledge

Project management

Leadership

Communication

Interpersonal skills

Risk assessment

Multinational experience

Coaching

Education

Bachelor in science

5+ years regulatory exp

Masters/PhD advantageous

Job description

US Tech Solutions is seeking a Regulatory Labeling Lead to provide strategic oversight of safety labeling variations for regulated pharmaceutical products, ensuring regulatory compliance and patient safety across global markets.

The role interfaces with PV, Regulatory Affairs Labeling, and Global Labeling Operations to establish robust labeling processes including CCDS variations, PRAC triggers, and monitoring of innovator and generic labels.