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Regulatory Affairs Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Marketing, Support
Projektbeschreibung
REFERENZNUMMER:
339938/11
IHRE AUFGABEN:
-Be responsible for leading some of the EU regulatory activities, including operational and strategic activities in drug development, centralised procedure pre- and post-marketing phases
-Preparation and submission for regulatory approval of clinical trial authorisation applications
-Support regulatory strategy and communication
-Coordination of clinical study report activities as required
-Labelling activities
-Coordination of periodic reports or other update to regulatory documents as required, e.g. PSUR, RMP, IB, CCDS
-Preparation of Orphan Drug annual reports for EU and US
IHRE QUALIFIKATIONEN:
-Mandatory previous experience in a pharmaceutical company or a CRO
-Minimum Bachelor degree in life science
-A solid experience in a similar role, responsible for EU regulatory affairs
-Demonstrated experience in regulatory activities in centralised procedure
-Experience in clinical trial applications
-Previous experience in orphan drugs will be highly appreciated
-Knowledge of EU regulatory affairs guidelines and regulations
-Fluency in English, both written and oral
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
339938/11
IHRE AUFGABEN:
-Be responsible for leading some of the EU regulatory activities, including operational and strategic activities in drug development, centralised procedure pre- and post-marketing phases
-Preparation and submission for regulatory approval of clinical trial authorisation applications
-Support regulatory strategy and communication
-Coordination of clinical study report activities as required
-Labelling activities
-Coordination of periodic reports or other update to regulatory documents as required, e.g. PSUR, RMP, IB, CCDS
-Preparation of Orphan Drug annual reports for EU and US
IHRE QUALIFIKATIONEN:
-Mandatory previous experience in a pharmaceutical company or a CRO
-Minimum Bachelor degree in life science
-A solid experience in a similar role, responsible for EU regulatory affairs
-Demonstrated experience in regulatory activities in centralised procedure
-Experience in clinical trial applications
-Previous experience in orphan drugs will be highly appreciated
-Knowledge of EU regulatory affairs guidelines and regulations
-Fluency in English, both written and oral
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges