Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Technical Drug Regulatory Affairs Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Marketing
Projektbeschreibung
REFERENZNUMMER:
263525/11
IHRE AUFGABEN:
-Represent the technical regulatory function on cross-functional teams and lead the interactions with global regulatory agencies
-Provide strategic leadership and regulatory guidance to the teams/functions on technical regulatory issues
-Provide global regulatory strategies to support products that have a biologic in combination with medical device component
-Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with the other disciplines
-Prepare integrated plans relating to the regulatory submissions or specific functional projects
-Successfully negotiate technical regulatory plans with affiliates and Health Authorities
IHRE QUALIFIKATIONEN:
-University degree in a scientific discipline
-Experience with large molecules
-Know-how in Regulatory CMC
-Working knowledge in core processes in large molecules
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
263525/11
IHRE AUFGABEN:
-Represent the technical regulatory function on cross-functional teams and lead the interactions with global regulatory agencies
-Provide strategic leadership and regulatory guidance to the teams/functions on technical regulatory issues
-Provide global regulatory strategies to support products that have a biologic in combination with medical device component
-Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with the other disciplines
-Prepare integrated plans relating to the regulatory submissions or specific functional projects
-Successfully negotiate technical regulatory plans with affiliates and Health Authorities
IHRE QUALIFIKATIONEN:
-University degree in a scientific discipline
-Experience with large molecules
-Know-how in Regulatory CMC
-Working knowledge in core processes in large molecules
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Marketing/Vertrieb, Sonstiges
Hays
-
Straße:
Willy-Brandt-Platz 1-3
-
Ort:
68161 Mannheim, Universitätsstadt, Deutschland