Senior Specialist/Manager, Regulatory Intelligence and Analytics

Tasks

• Coordinate regulatory deliverables
• Disseminate legislative requirement changes
• Ensure compliance with procedures and trackers
• Escalate out-of-scope issues
• Identify and mitigate regulatory risks
• Lead regulatory intelligence projects
• Maintain regulatory intelligence database
• Monitor budgets and project hours
• Perform regulatory intelligence quality control
• Provide regulatory strategic input
• Provide training, coaching, and mentoring
• Provide vendor performance feedback
• Represent department in meetings and audits
• Review and contribute to SOPs and guidance
• Support preparation for audits and inspections
• Support proposal development

Perks/Benefits

• English as company language
• Friendly supportive working environment
• International collaboration
• Remote work
• Training and career development

Skills/Tech-stack

Audits | Data Management | GVP | ICH GCP | Inspections | Operating procedures | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Risk Management | Standard Operating Procedures