Regulatory Affairs Associate III

Position: Regulatory Affairs Associate III # 26-21316

Duration: 10 months Contract

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.

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 One Track.
• 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.

Skills:

• 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.

Education and experience:

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
• Relevant advanced degree in science or business is preferred. Certification a plus.
• 5+ years of regulatory, pharmaceutical or device experience.

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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