Sr. Manager CMC Regulatory Affairs
Location: GermanySIRE® ist der Marktführer in der Recruitment-Branche der Life Sciences Industrie. Wir glauben, dass die Recruitment-Branche noch einige Verbesserungen in Technologie und inhaltlicher Innovation vornehmen kann. Wir lieben Technologie und in einem Markt, der auf Life-Science orientiert ist und sich auf den wissenschaftlichen Aspekt konzentriert, können wir nicht zurückbleiben; wir betreiben Recruitment-Wissenschaft. Wir investieren einen großen Teil unseres Umsatzes in Technologie, wodurch wir einzigartige Ressourcentechnologie verwenden können. Durch die Verwendung von hochgradig entwickelten Algorithmen, ist es unserem Team an Ressourcen- & Datenstrategen© möglich, das am meisten ausgebaute, detaillierteste und vollständige Life Sciences Netzwerk in Europa zu erhalten. Durch diese großen Datenmengen (Big Data) ist es uns möglich, Reverse Recruitment© zu betrieben: wir analysieren erst tief gehend den Markt, bevor wir uns in den Markt begeben. Da wir den gesamten Markt analysieren, können wir Fakten und Daten vergleichen. Dadurch können wir Facts & Big Data Recruitment© betrieben, und sicherstellen, dass wir oder besser gesagt, Sie, die besten Karriere finden.
Management of document collection for phase III & IV development tasks like CQA assessment, process characterization and validation, as well as control strategy formation
Arrangement of quality sections for BLA & MAA as well as for IMPD and IND
Alignment of filing activities within the CMC team
Tracking of relevant regulatory interactions between the client, external partners, and regulatory agencies
Contribution to meetings as CMC Regulatory Affairs expert for guidance and regulations related to GMP
Observation of regulatory guidance concerning revisions or additions
Substantial experience in the pharmaceutical or biotechnological industry
At least 3 years of working experience in the fields of GMP and RA, preferably with a focus biologics
Experience with CMC requirements for phase III & IV clinical development and compilation of module 3 submission
Experience in the most recent Regulatory Affairs related processes in development for biologics
Motivated team player with strong interpersonal abilities and a desire to represent CMC-RA in various working groups
Excellent communication skills (German & English)
The Company
Our client is a world-leading pharmaceutical company, with various products about to enter the marketRole Description
Sr. Manager CMC Regulatory AffairsResponsibilities
Coordination of RA aspects concerning the collaboration with CMOs and partners during CMC advancementManagement of document collection for phase III & IV development tasks like CQA assessment, process characterization and validation, as well as control strategy formation
Arrangement of quality sections for BLA & MAA as well as for IMPD and IND
Alignment of filing activities within the CMC team
Tracking of relevant regulatory interactions between the client, external partners, and regulatory agencies
Contribution to meetings as CMC Regulatory Affairs expert for guidance and regulations related to GMP
Observation of regulatory guidance concerning revisions or additions
Requirements
Degree in Life SciencesSubstantial experience in the pharmaceutical or biotechnological industry
At least 3 years of working experience in the fields of GMP and RA, preferably with a focus biologics
Experience with CMC requirements for phase III & IV clinical development and compilation of module 3 submission
Experience in the most recent Regulatory Affairs related processes in development for biologics
Motivated team player with strong interpersonal abilities and a desire to represent CMC-RA in various working groups
Excellent communication skills (German & English)
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