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International DRA Project Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
REFERENZNUMMER:
369606/11
IHRE AUFGABEN:
-Provide regulatory strategy for the international countries (outside the following countries: US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
-Maintain regulatory knowledge for international countries (new registrations, variations & renewals of marketed products)
-Liaise and coordinate all documentation, submissions and activities with affiliates for NCE dossiers and life cycle of marketed products
-Respond to health authority questions in coordination with Global DRA Project Leader and project teams
-Coordinate the archiving of submitted registration dossiers and other relevant health authority communication
-Evaluate and review the regulatory activities of potential and existing business partners' contracts and quotations
IHRE QUALIFIKATIONEN:
-Degree in Life Science and profound experience in International Drug Regulatory Affairs
-Knowledge and experience of global regulatory processes
-Ability to work in multicultural environment
-Excellent communication, interpersonal, negotiation and problem solving skills Capable of working independently as well as effective team player
-Accuracy and good project management skills
-Excellent command of spoken and written English, other languages are of advantage
WEITERE QUALIFIKATIONEN:
Regulatory affairs assistant
369606/11
IHRE AUFGABEN:
-Provide regulatory strategy for the international countries (outside the following countries: US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
-Maintain regulatory knowledge for international countries (new registrations, variations & renewals of marketed products)
-Liaise and coordinate all documentation, submissions and activities with affiliates for NCE dossiers and life cycle of marketed products
-Respond to health authority questions in coordination with Global DRA Project Leader and project teams
-Coordinate the archiving of submitted registration dossiers and other relevant health authority communication
-Evaluate and review the regulatory activities of potential and existing business partners' contracts and quotations
IHRE QUALIFIKATIONEN:
-Degree in Life Science and profound experience in International Drug Regulatory Affairs
-Knowledge and experience of global regulatory processes
-Ability to work in multicultural environment
-Excellent communication, interpersonal, negotiation and problem solving skills Capable of working independently as well as effective team player
-Accuracy and good project management skills
-Excellent command of spoken and written English, other languages are of advantage
WEITERE QUALIFIKATIONEN:
Regulatory affairs assistant
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges