Beschreibung
* Preparation of Quality Reference Files before launch of the medicinal product* Risk Assessment for BOPPs
* Preparation of risk assessments
* Overview of submitted reports and planning of necessary testing activities
* Evaluation, compliance check and gap analysis of a registration dossiers from external partners intended for in-licensing (Due Diligence)
* Support to answer deficiency letters from Health Authorities
* Evaluation and reviewing of upcoming changes related to initial launches or initial proactive global harmonization of compliance status
* Operational / hands on CMC Writing experience for Pharma products (generics a plus)
* Technical dossier expertise (eg. analytical / qualification) either leading or reviewing / participating in compliance gap analysis and closure
* Experience in regulatory registration processes for initial submission and maintenance activities (incl. in EU DCP/MRP, Latin America)
* Strong English-skills
Kontaktperson: Personalreferentin Frau Julia-Elisabeth Kratz
FERCHAU GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt