CMC Regulatory Consultant
Il y a 2 mois
RisOrangis, Île-de-France
Ividata Life Sciences
Temps plein
Senior CMC Reg ConsultantThe Regulatory CMC Division of Ividata Life Sciences is seeking a highly skilled Senior CMC Reg Consultant to provide regulatory support for the initial submission in EU and the first line international countries for a small molecule product in development.
Key Responsibilities:
- Manage all documents through the document management system
- Deliver late phase CMC Regulatory documents for EU submission and the first line international countries
- Provide CMC Regulatory support to the CMC Technical team in relation to EU requirements and the requirements for the first line international countries
Requirements:
- English: read, written, spoken
- Experience in managing the delivery of late phase CMC Regulatory documents for EU submission and the first line international countries
- Project management experience is a plus
