Senior Specialist/Manager, Regulatory Intelligence and Analytics

Tasks

• Conduct quality control of regulatory intelligence screening
• Coordinate regulatory deliverables
• Design and review SOPs and guidance
• Disseminate regulatory changes
• Ensure compliance with procedures and processes
• Escalate out-of-scope issues
• Identify regulatory risks
• Lead regulatory intelligence projects
• Maintain regulatory intelligence database
• Monitor project budgets and hours
• Provide regulatory strategic input
• Provide vendor performance feedback
• Support audits and inspections
• Support proposal development and budgets
• Train coach and mentor team members

Perks/Benefits

• Friendly Supportive Work Environment
• Remote work
• Training and career development
• Work-life balance

Skills/Tech-stack

Audit preparation | Budget Monitoring | Compliance Management | Database Management | ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development | Vendor management