Regulatory Affairs Associate

Creative Solutions Services, LLC; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Manager, Process Excellence within Regulatory Affairs to oversee issue and CAPA management programs and drive cross-functional process improvements. The role supports inspection readiness, audit responses, and change management for legacy regulatory processes.

The ideal candidate will have 5+ years of regulatory or quality experience, strong analytical and project-management skills, and the ability to influence across a matrixed organization.

Qualifications

• Bachelor's degree in life sciences; advanced degree preferred.
• Certification a plus.

Responsibilities

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are logged, assessed, tracked, and resolved.
• Triage RAIM issue records to determine severity, impact, and next steps.
• Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance.
• Project manage Exception Reports with cross-functional stakeholders to identify root causes and drive corrective actions.
• Collaborate with Regulatory Affairs leaders, Quality, and other functions to ensure timely, coordinated issue management.
• Support during audits and inspections, including documentation coordination and response support.
• Manage legacy integrations for Regulatory Affairs processes through change plans.
• Ensure process documentation, issue records, and change plans align with governance.
• Partner with stakeholders to communicate and adopt process changes.

Skills

Stakeholder management

Analytical skills

Communication

Project management

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Summary:

• The Manager, Process Excellence within Regulatory Affairs is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations.
• This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements.
• Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.

Key Responsibilities:

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved.
• Triage RAIM issue records to determine severity, impact, and appropriate next steps.
• Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance.
• Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve Client processes.
• Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effective.
• May provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as needed.
• Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack.
• Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations.
• Partner with stakeholders to support effective communication, implementation, and adoption of process changes.

Required Education:

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred.
• Certification a plus

Required Experience:

• 5+ years of regulatory, pharmaceutical or device experience.
• Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred
• Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows.
• Experience supporting audit and inspection readiness in a regulated environment.
• Strong organizational, analytical, communication, facilitation, and stakeholder management skills.
• Ability to manage multiple priorities and work effectively across functions and levels.
• Ability to influence without direct authority and work in a matrixed environment.