About this role
Role Overview
- Preparation, Organization & Coordination of Local Regulatory Documentation
- Provide Local Input for Post‑Approval Changes & Change Control
- Support in Audits, Inspections & Regulatory Compliance
Requirements
- Strong knowledge of global regulatory guidelines
- Experience in lifecycle management: renewals, variations, PSUR/PBRER submissions, label updates, CMC changes
- Familiarity with change control processes
- Good documentation skills
- Ability to work effectively with cross-functional and global teams
Benefits
- Health insurance
- Professional development