Senior Specialist/Manager, Regulatory Intelligence and Analytics
Tasks
- Conduct quality control of regulatory intelligence screening
- Coordinate regulatory deliverables
- Design and review SOPs and guidance
- Disseminate regulatory changes
- Ensure compliance with procedures and processes
- Escalate out-of-scope issues
- Identify regulatory risks
- Lead regulatory intelligence projects
- Maintain regulatory intelligence database
- Monitor project budgets and hours
- Provide regulatory strategic input
- Provide vendor performance feedback
- Support audits and inspections
- Support proposal development and budgets
- Train coach and mentor team members
Perks/Benefits
Skills/Tech-stack
Audit preparation | Budget Monitoring | Compliance Management | Database Management | ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development | Vendor management
Education
Associate Degree | Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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