Regulatory Affairs Manager

Regulatory Affairs Manager

Deerfield, IL (HYBRID: onsite 3 days a week)

12 months with the possibility of extension/conversion

$44/hr w2

Provide strategic oversight of safety-related labeling variations that impact regulated pharmaceutical drug products while ensuring regulatory compliance and consistent communication of product information across global markets. Serve as the key interface between Pharmacovigilance (PV), the Regulatory Affairs Labeling Team, and Global Labeling Operations to ensure safety labeling processes are owned, established, and executed effectively. Own and drive safety labeling processes for GRA, including CCDS and associated Safety Variations, generic labeling and monitoring of innovator labels, and monitoring of PRAC and MOH triggers.

Oversee generic labeling surveillance and innovator-label monitoring, including oversight of PRAC recommendations and coordination of NCRs. Lead continuous improvement through CCDS metrics and KPI reporting, and provide safety labeling governance by escalating risks associated with overdue safety variations.

Bachelor’s degree (or country equivalent) in a scientific discipline; a Master’s and/or PhD is an advantage. Minimum of 5 years of regulatory experience in Regulatory Affairs (RA) or a related field, including experience managing people or projects. Strong scientific knowledge and the ability to multitask and prioritize 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, including the ability to identify compliance risks independently and escape when necessary.

Opportunity to directly influence patient safety through safety labeling governance and consistent global product information. Ownership of critical systems and processes, including serving as System Owner for Fluxguard and CCDS/Safety Labeling Tracking. Visibility and impact across cross-functional teams, including support for PV and RA inspections related to safety labeling. Chance to strengthen the safety variation submission process by developing training materials and supporting related system changes.

A role built for continuous improvement, where you can lead KPI reporting, drive process enhancements, and elevate compliance outcomes.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• 401(k)
• Plus Match
• Weekly Pay