Senior Specialist/Manager, Regulatory Intelligence and Analytics

Tasks

• Contribute to SOP design and review
• Coordinate regulatory deliverables
• Disseminate legislative changes
• Ensure compliance with company procedures
• Ensure regulatory deliverables meet targets
• Escalate out-of-scope issues
• Identify and mitigate regulatory risks
• Lead regulatory intelligence projects
• Maintain regulatory intelligence database
• Manage project budgets and hours
• Perform quality control of regulatory intelligence screening
• Provide departmental representation
• Provide regulatory strategic input
• Provide vendor performance feedback
• Support audits and inspections
• Support proposal development
• 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 Support | Database Management | ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Assurance | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development