Senior Specialist/Manager, Regulatory Intelligence and Analytics

Tasks

• Assess and provide feedback on vendors
• Coordinate regulatory deliverables
• Disseminate regulatory changes
• Ensure compliance with company procedures and processes
• Escalate out-of-scope issues
• Identify regulatory risks and implement preventive measures
• Lead regulatory intelligence projects
• Maintain regulatory intelligence database
• Manage regulatory timelines trackers templates
• Monitor project budgets and hours vs budget
• Perform regulatory intelligence quality control
• Prepare for audits and inspections
• Provide department representation for projects
• Provide regulatory strategic input
• Provide training, coaching, mentoring
• Review and design SOPs and guidance
• Support proposal development and budgets

Perks/Benefits

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

Skills/Tech-stack

Audit preparation | GCP | GVP | ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development