Senior Specialist/Manager, Regulatory Intelligence and Analytics

Tasks

• Contribute to SOP development and review
• Coordinate regulatory projects
• Disseminate regulatory changes
• Ensure compliance with company procedures
• Escalate out-of-scope issues
• Identify and mitigate regulatory risks
• Lead regulatory deliverables
• Maintain regulatory intelligence database
• Monitor project budgets and hours
• Perform regulatory intelligence screening
• Provide regulatory strategic input
• Provide training, coaching, and mentoring
• Provide vendor performance feedback
• Support audits and inspections
• Support proposal development

Perks/Benefits

• Friendly supportive working environment
• Remote work opportunity
• Training and career development
• Work-life balance

Skills/Tech-stack

Audit Support | Budget Monitoring | Compliance | ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development