- Our company is a company of the ALTEN GROUP, the European leader in engineering.
- Our company is a Contract Research Organization (CRO) providing services to the life science industry for 10 years.
- Our mission is to support the key players of the pharmaceutical industry in France and Europe on different types of services: In-sourcing (CRO) and Outsourcing in environments as diverse as Bio metrics, Regulatory Affairs, Clinical Research, Pharmacovigilance and Quality Assurance.
- Writing CMC parts of regulatory variations
- Writing Module 2 of regulatory files derived from completed eCTD Modules 3
- Writing IMPDs as far as CMC information is concerned
- Writing Responses to Questions raised by Regulatory Authorities on CMC matters
- Update of internal tracking system linked to their CMC activities
- Involvement in internal initiatives for improvement of processes/ ways of working
- Knowledge and understanding of regulatory legislation and guidelines related to CMC, procedural and administrative aspects.
- Previous experience in writing scientific / regulatory documents.
- Experience in preparation of cover letters, application forms, letters of intent would be a plus
- Team working skills, including optimal reporting and alerting capabilities
- Skills in the management of IT Tools ( Regulatory databasis, Documentum like tool) , Working English