Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject)
5+ years of experience in regulatory, pharmaceutical or device fields
Experience managing issue/CAPA systems and exception reporting
Strong organizational and analytical skills
Ability to manage multiple priorities effectively
Skills in communication and stakeholder management
Experience in supporting audit and inspection readiness
Responsibilities
Manage the Regulatory Affairs Issue and CAPA Management system (RAIM)
Triage RAIM issue records to determine severity and impact
Escalate issues to Exception Reports based on compliance impact
Project manage Exception Reports with cross-functional teams
Collaborate with Regulatory Affairs and Quality leaders for effective issue management
Support audits and inspections by coordinating documentation
Manage change plans for legacy company integrations
Benefits
Collaborative cross-functional team environment
Opportunity to enhance regulatory processes
Support for career advancement and professional growth
Involvement in critical compliance activities
Engagement with various stakeholders across the organization
Full 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.
bility to manage multiple priorities and work effectively across functions and levels.
bility to influence without direct authority and work in a matrixed environment.
