Regulatory Affairs Manager

Safety Labeling Regulatory Affairs Specialist

Location: Deerfield, IL 60015

Work Arrangement: Onsite

Pay Rate: $40–$43/hour on W2

Employment Type: Contract

Position Summary

Responsible for strategic oversight of safety-related labeling variations impacting regulated pharmaceutical drug products while ensuring regulatory compliance, patient safety, and consistent communication of product information across global markets.

Essential Duties and Responsibilities

• Serve as a key interface between Pharmacovigilance (PV), the Regulatory Affairs Labeling Team, and Global Labeling Operations.
• Establish and manage safety labeling processes, including:
• Company Core Data Sheet (CCDS) and associated safety variations.
• Generic labeling and innovator-label monitoring.
• PRAC and Ministry of Health (MOH) triggers.
• Oversee generic labeling surveillance and innovator-label monitoring.
• Monitor and oversee PRAC recommendations.
• Lead continuous improvement initiatives and KPI reporting, including CCDS metrics and coordination of Nonconformance Reports (NCRs).
• Provide safety labeling governance and compliance oversight for safety-related labeling changes across global markets.
• Identify and escalate compliance risks associated with overdue safety variations.
• Develop training materials to improve safety variation submission processes and support related system changes.
• Serve as the system owner for Fluxguard and CCDS/Safety Labeling Tracking.
• Support Pharmacovigilance and Regulatory Affairs inspections related to safety labeling.
• Represent the Global Regulatory Affairs function at Pharmacovigilance Safety Signal Meetings.

Qualifications

• Strong scientific knowledge and understanding of regulatory requirements.
• Ability to multitask, prioritize responsibilities, and manage competing deadlines.
• Ability to work effectively in multinational and multicultural environments.
• Strong technical and management skills.
• Proven ability to manage complex projects and timelines within a matrix team environment.
• Excellent interpersonal, communication, negotiation, and presentation skills.
• Ability to lead, coach, and support team members.
• Ability to independently identify compliance risks and escalate issues when necessary.

Education and Experience

• Bachelor's degree or country equivalent in a scientific discipline.
• Master's degree and/or PhD preferred.
• Minimum of 5 years of regulatory experience in Regulatory Affairs or a related field, including experience managing people or projects.