Senior Specialist/Manager, Regulatory Intelligence and Analytics
Warsaw, Masovian Voivodeship, Poland
PLN 227K-354K (estimate) Senior-level Full Time
Tasks
- Contribute to SOP design and review
- Coordinate regulatory deliverables
- Disseminate regulatory change updates
- Ensure compliance with regulatory procedures
- Identify regulatory risks and implement preventive measures
- Lead regulatory intelligence projects
- Line manage team members
- Maintain regulatory intelligence database
- Monitor project budgets and escalate issues
- Perform quality control of regulatory intelligence screening
- Provide performance feedback to vendors
- Provide regulatory strategic input
- Provide training, coaching, and mentoring
- Represent department in meetings
- Support audits and inspections preparation
- Support proposal development and budgeting
Perks/Benefits
Skills/Tech-stack
Budget Monitoring | ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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