Beschreibung
* Support roll out and maintenance of a number of products in the frame of a licensing project with and external partner* Coordination of multiple regulatory procedures and pre-submission activities in EU and the non-ICH geographies
* Taking Regulatory Affairs of GxP and FDA into account
* Excellent practical experience in Regulatory Affairs Management
* Excellent experience with European Regulatory Procedures
* Outstanding expertise with International Regulatory Procedures
* Many years of Project Management competencies
* Strong Communication Skills
* English: business fluent
* German: nice to have
* Experiences with biological, medicinal products, clinical or allergen products would be helpful
Schlagwörter:
Deutsch, Englisch, FDA/IVD, Kommunikation, Projektmanagement, Zulassungen, Regulatory Affairs Management,
Kontaktperson: Personalreferentin Frau Hatmane Berisha
FERCHAU Engineering GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt