Senior Manager, Regulatory Affairs Process Excellence

📋 Description

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are
• 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
• Project manage Exception Reports in partnership with cross-functional stakeholders to identify root
• Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions
• May provide support during internal and external audits and inspections, including coordination of

🎯 Requirements

• Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology
• Preferred Education: Relevant advanced degree in science or business is preferred. Certification a
• Required Experience: 8+ years of regulatory, pharmaceutical or device experience
• Experience in Regulatory Affairs, Quality, process excellence, business process management, or
• Experience managing issue/CAPA systems, exception reporting, or comparable compliance and
• Experience supporting audit and inspection readiness in a regulated environment

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligible to participate in long-term incentive programs