Global Safety Labeling Lead

Spectraforce Technologies, Inc.; Deerfield (IL); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Regulatory Affairs Manager in Deerfield, IL to oversee safety label variations and ensure global regulatory compliance.

The role interfaces with PV and labeling teams to drive CCDS processes, monitor generic and innovator labeling, and lead improvements in safety labeling governance. The candidate will develop training for variation submissions, own Fluxguard and CCDS tracking, and support inspections related to safety labeling across markets.

Qualifications

• Bachelor's degree or country equivalent in a scientific discipline; Masters/PhD preferred.
• Minimum 5 years regulatory experience in RA or related field, including managing people or projects.
• Strong regulatory knowledge and ability to identify compliance risks.
• Ability to lead and coach others in a matrix team environment.

Responsibilities

• Key interface between PV, Regulatory Affairs Labeling Team and Global Labeling Operations.
• Ownership and establishment of safety labeling processes for GRA including CCDS and safety variations.
• Oversee generic labeling surveillance and innovator-label monitoring.
• Oversee PRAC recommendations.
• Lead KPI reporting including CCDS metrics and NCR coordination.
• Safety labeling governance and compliance oversight across global markets.
• Develop training materials for safety variation submissions and system changes.
• System owner for Fluxguard and CCDS/Safety Labeling Tracking.
• Support PV and RA inspections related to safety labeling.
• Represent GRA function on PV Safety Signal Meeting.

Skills

Scientific knowledge

Multitasking ability

Multicultural environment

Regulatory knowledge

Management skills

Project leadership

Communication skills

Negotiation skills

Technical skills

Leadership coaching

Compliance risk identification

Education

Bachelor's degree in a scientific field

Masters or PhD (advantage)

Tools

Fluxguard

CCDS tracking

Job description

Spectraforce Technologies, Inc. seeks a Regulatory Affairs Manager in Deerfield, IL to oversee safety label variations and ensure global regulatory compliance.

The role interfaces with PV and labeling teams to drive CCDS processes, monitor generic and innovator labeling, and lead improvements in safety labeling governance. The candidate will develop training for variation submissions, own Fluxguard and CCDS tracking, and support inspections related to safety labeling across markets.