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ECTD Regulatory Submission Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Xml
Projektbeschreibung
REFERENZNUMMER:
311692/11
IHRE AUFGABEN:
-Planning, compiling, coordinating and tracking eCTD submissions of EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed
-Check electronic documents and reformat to standards as required, to ensure eCTD compliance
-Be responsible for submission compilation: assigning metadata, locations within the eCTD modular structure building XML backbone, eCTD leaf titles, lifecycle operators in accordance with company procedures and standards
-Liaise with a submissions outsourcing partner on these activities when required by DRA management
IHRE QUALIFIKATIONEN:
-Experience in making electronic submissions in eCTD format
-Fundamental understanding of eCTD regulatory guidance in the EU
-Understanding of eCTD regulatory guidance in countries outside of EU & US (e.g. Saudi Arabia, Thailand, etc.) would be an advantage
-Fluency in English
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
311692/11
IHRE AUFGABEN:
-Planning, compiling, coordinating and tracking eCTD submissions of EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed
-Check electronic documents and reformat to standards as required, to ensure eCTD compliance
-Be responsible for submission compilation: assigning metadata, locations within the eCTD modular structure building XML backbone, eCTD leaf titles, lifecycle operators in accordance with company procedures and standards
-Liaise with a submissions outsourcing partner on these activities when required by DRA management
IHRE QUALIFIKATIONEN:
-Experience in making electronic submissions in eCTD format
-Fundamental understanding of eCTD regulatory guidance in the EU
-Understanding of eCTD regulatory guidance in countries outside of EU & US (e.g. Saudi Arabia, Thailand, etc.) would be an advantage
-Fluency in English
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung