Senior Specialist/Manager, Regulatory Intelligence and Analytics

Tasks

• Contribute to SOP development and reviews
• Coordinate regulatory deliverables
• Disseminate regulatory requirement changes
• Ensure compliance with company procedures
• Ensure team awareness of tasks and timelines
• Escalate issues out of scope
• Identify and mitigate regulatory risks
• Lead regulatory intelligence projects
• Maintain regulatory intelligence database
• Manage regulatory deliverable timelines
• Monitor budget and hours versus budget
• Perform regulatory intelligence screening
• Prepare for audits and inspections
• Provide regulatory strategic input
• Provide vendor performance feedback
• Support proposal development and budgeting
• Train coach and mentor junior staff

Perks/Benefits

• Diversity, equity & inclusion
• Friendly Supportive Work Environment
• Personal and professional growth
• Remote work opportunity
• Training and career development
• Work-life balance

Skills/Tech-stack

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