Senior Regulatory Affairs Lead-Safety Labeling & Compliance

Experis Technology Group; Deerfield (IL); Hybrid; USD 50,000 - 71,000; Full time

Benefits offered by this job

Hybrid work arrangement

Onsite 3 days a week

Job summary

Experis Technology Group in Deerfield, IL, seeks a Regulatory Affairs Manager for a 12-month hybrid role. You will provide strategic oversight of safety-related labeling variations that affect regulated drug products and ensure regulatory compliance across global markets.

You will be the key interface among Pharmacovigilance, the Regulatory Affairs Labeling Team, and Global Labeling Operations to ensure safety labeling processes are owned, established, and executed effectively.

Qualifications

• Minimum 5 years of regulatory experience in Regulatory Affairs or a related field.
• Experience managing people or projects.
• Strong scientific knowledge with multitasking in a fast-moving, compliance-focused environment.
• Ability to work effectively in a multinational/multicultural environment and collaborate across matrix teams.
• Demonstrated regulatory knowledge, management skills, and strong interpersonal, communication, and presentation abilities.

Responsibilities

• Provide strategic oversight of safety-related labeling variations across global markets.
• Serve as the key interface between PV, RA Labeling Team, and Global Labeling Operations to ensure governance.
• Own and drive safety labeling processes for GRA, including CCDS and Safety Variations, generic labeling and monitoring.
• Oversee generic labeling surveillance and innovator-label monitoring, including oversight of PRAC recommendations and NCR coordination.
• Lead continuous improvement through CCDS metrics and KPI reporting and escalate risks related to overdue safety variations.

Skills

Regulatory knowledge

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in a scientific field

Master’s/PhD advantageous

Job description

Experis Technology Group in Deerfield, IL, seeks a Regulatory Affairs Manager for a 12-month hybrid role. You will provide strategic oversight of safety-related labeling variations that affect regulated drug products and ensure regulatory compliance across global markets.

You will be the key interface among Pharmacovigilance, the Regulatory Affairs Labeling Team, and Global Labeling Operations to ensure safety labeling processes are owned, established, and executed effectively.