Availability: Dependent on length, timescale and scope of project
Main Expertise
Regulatory
Location and Availability
France
Contact us
For more details on individual profiles and their availability please email kubosourcing@crosnt.com
Tel: +44 (0) 1908 488787
Profile #1101588
Profile #1101588
Key Skills
- Regulatory compliance
- Regulatory strategy
- Support for submissions including STED filings for Medical Devices, ASEAN CTD dossier, EU MA filings
- Definition and implementation of action plan
- Project Management
- Team Management (coordination of international teams, chairing meetings)
Experience
- 10 years’ experience within Regulatory Affairs
- Consulting support for submissions including STED filings for Medical Devices, ASEAN CTD dossier, EU MA filing
- Due diligence / Gap Analysis
- Regulatory compliance
- Regulatory strategy
- Definition and implementation of action plan
- Liaising with marketing, supply chain and R&D teams
- Implementation of marketing plan
- CMC writing: CTD, IMPD, STED
- Scientific Advice (SA) Meetings
- Clinical trial application
- Paediatric Investigation Plan (PIP)
- Life cycle management
- EU MA applications (MRP, DCP, CP)
Education
- PhD Medicinal and Organic Chemistry
- Master 2 – Industrial Pharmacy