Regulatory Affairs Associate

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.