Senior Specialist/Manager, Regulatory Intelligence and Analytics
Tasks
- Contribute to SOP development and review
- Coordinate regulatory deliverables
- Disseminate regulatory changes
- Ensure compliance with procedures
- Escalate issues
- Identify and mitigate regulatory risks
- Lead regulatory projects
- Line manage team members
- Maintain regulatory intelligence database
- Monitor project budgets
- Perform regulatory intelligence screening
- Prepare for audits and inspections
- Provide regulatory strategic input
- Provide training, coaching, and mentoring
- Provide vendor performance feedback
- Support proposal development
- Track hours vs budget
Perks/Benefits
- Friendly Supportive Work Environment
- Global collaboration
- Training and career development
- Work-life balance
Skills/Tech-stack
ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence
Education
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