Senior Specialist/Manager, Regulatory Intelligence and Analytics
Tasks
- Contribute to SOP design and review
- Coordinate regulatory deliverables
- Disseminate regulatory requirement changes
- Ensure compliance with regulatory procedures and trackers
- Identify and mitigate regulatory risks
- Lead regulatory intelligence projects
- Line manage team members
- Maintain regulatory intelligence database
- Monitor project budgets and hours
- Perform quality control of regulatory intelligence screening
- Provide regulatory strategic input
- Provide training, coaching, and mentoring
- Provide vendor performance feedback
- Support audits and inspections
- Support proposal development
Perks/Benefits
- Flexible work-life balance
- Supportive working environment
- Training and career development opportunities
Skills/Tech-stack
Audit Support | Budget tracking | Coaching | Database Management | ICH GCP | ICH GVP | Mentoring | Pharmacovigilance | Project Management | Quality Control | Regulatory Compliance | Regulatory Intelligence | Risk Management | SOP Development | Training delivery
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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