Clinical Trial Regulatory Submission
This is a Clinical Regulatory / Clinical Trial Submissions role.
The ideal candidate should have 4+ years in Pharma/CRO, with hands-on experience managing Clinical Trial Application (CTA) submissions, particularly EU CTR and ROW, while coordinating global cross-functional teams.
Core profile to target:
- Clinical Trial Applications (CTA) / regulatory submissions
- EU CTR submissions – is a MUST
- ROW (Rest of World) submissions
- End-to-end submission planning and project management
- Clinical/regulatory documentation
- Global/matrix stakeholder management
- Submission timelines, tracking & KPIs
- Risk, issue and dependency management
- Quality investigations / compliance
- Pharma / CRO / Clinical Research environment
- Life Sciences / Pharmacy background