Senior Specialist/Manager, Regulatory Intelligence and Analytics
Tasks
- Contribute to SOP design and review
- Coordinate regulatory deliverables
- Disseminate regulatory changes
- Ensure compliance with procedures and processes
- Escalate issues and out of scope items
- Identify and mitigate regulatory risks
- Lead regulatory intelligence projects
- Line manage team members
- Maintain regulatory intelligence database
- Monitor project budgets and hours
- Perform regulatory intelligence screening
- Provide regulatory strategy input
- Provide training, coaching, and mentoring
- Provide vendor performance feedback
- Support audits and inspections
- Support proposal development
Perks/Benefits
- Friendly supportive working environment
- Remote work
- Training and career development
- Work with global teams
Skills/Tech-stack
GCP guidelines | GVP | ICH GCP | ICH-GCP Guidelines | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
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