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Regulatory Affairs Process Excellence Manager
Contract: North Chicago, Illinois, US
Salary Range: 50.00 - 60.00 | Per Hour
Job Code: 371340
End Date: 2026-09-25
Days Left: 17 days, 12 hours left
Hi there, This is Siddhi, Talent Expert with Collabera LLC. Hope this message finds you well! We're hiring for Top performers encouraged to apply positions are filling fast! If interested, Let's connect and don't miss out apply today and let's talk about your next big opportunity!
Email: siddhi.kadakia@collabera.com | Phone: (847)-440-1112.
Client Industry: Pharmaceutical/Medical Device/Biotechnology
Job Title: Regulatory Affairs Process Excellence Manager
Location: North Chicago, IL 60064
Shift: Hyrid (onsite Tues, Wed, Thurs)
Duration: 10 Months Contract (++ possibility of extension based on performance and business needs);
Pay Rate: $50.00 to $60.00 Per Hour
Job Description :
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.
Must Have Hands On Experience Required
- Experience triaging issue records based on severity, business impact, risk, and compliance significance.
- Experience determining when an issue should be escalated to an Exception Report based on risk, compliance impact, or process significance.
- Experience project managing Exception Reports from initiation through root-cause identification, corrective actions, and closure.
- Experience partnering with Business Process Owners, Quality, Regulatory Affairs leaders, and cross-functional stakeholders to resolve issues and improve processes.
- Experience supporting management of change activities and implementation of process changes within Regulatory Affairs.
- Experience maintaining process documentation, issue records, CAPA records, and change plans in accordance with governance expectations.
- Ability to facilitate issue-management meetings and stakeholder discussions and keep actions moving toward resolution.
- Experience identifying whether corrective actions are appropriate and fit for purpose, rather than simply documenting the issue.
- Experience providing status reporting, timeliness updates, and ad hoc data/information to Regulatory Affairs leadership.
- Experience working in a matrixed environment with cross-functional teams and multiple organizational levels.
- Ability to support process improvement and adoption of new or revised processes.
- Experience working with legacy system/process integrations or transitioning established processes into new organizational environments.
- Ability to quickly understand new systems, processes, and business workflows with limited direction.
- Strong facilitation and analytical skills in addition to communication and stakeholder-management skills.
- Experience supporting internal audits, including preparing documentation and coordinating follow-up actions.
- Ability to distinguish between administrative support and true ownership of investigations, CAPAs, and issue records.
- Experience identifying process gaps, recurring issues, or trends that may require broader process improvement.
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Ability to manage time-sensitive compliance activities while maintaining accurate documentation and governance requirements.
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 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.
Qualifications
- Required Education: Bachelor's/Master/Phd 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.
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Ability to influence without direct authority and work in a matrixed environment
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).
Job Requirement
- CAPA
- Investigations
- Compliance
- Regulatory
- Quality
- Exceptions
- Root-Cause
- Audits
- Inspection-Readiness
- Documentation
- Issue-Management
- Process-Excellence
- Change-Management
- Stakeholder-Management
- Facilitation
- Communication
- Analytics
- Prioritization
- Governance
- RAIM
- OneTrack
- TrackWise
- SoulTracks
- Pharma
- Medical-Device
- Process-Improvement
- Influencing
Reach Out to a Recruiter
- Recruiter
- Phone
- Siddhi Kadakia
- siddhi.kadakia@collabera.com
Apply Now
Apply Now
