Senior Specialist/Manager, Regulatory Intelligence and Analytics
Tasks
- Contribute to SOP development and reviews
- Coordinate regulatory deliverables
- Disseminate regulatory requirement changes
- Ensure compliance with company procedures
- Ensure team awareness of tasks and timelines
- Escalate issues out of scope
- Identify and mitigate regulatory risks
- Lead regulatory intelligence projects
- Maintain regulatory intelligence database
- Manage regulatory deliverable timelines
- Monitor budget and hours versus budget
- Perform regulatory intelligence screening
- Prepare for audits and inspections
- Provide regulatory strategic input
- Provide vendor performance feedback
- Support proposal development and budgeting
- Train coach and mentor junior staff
Perks/Benefits
- Diversity, equity & inclusion
- Friendly Supportive Work Environment
- Personal and professional growth
- Remote work opportunity
- Training and career development
- Work-life balance
Skills/Tech-stack
Audit preparation | Compliance Management | ICH GCP | ICH GVP | Pharmacovigilance | Project Management | Quality Control | Regulatory Affairs | Regulatory Intelligence | Risk Management | SOP Development
Education
Associate Degree | Bachelor of Engineering | Bachelor of Science | Master of Science
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