Senior Manager Regulatory CMC Biosimilars (m/w/d)
Fresenius Kabi Austria GmbH - - Österreich, Deutschland
Fresenius Kabi Austria, with headquarters in Graz and a further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region.
Shortfacts
Einsatzort
Österreich/Deutschland
Ausmaß
Vollzeit
Eintrittsdatum
ab sofort
Anstellungsverhältnis
unbefristet
We are caring for our employees
* verlässlicher Arbeitgeber
* starkes globales Wachstum
* internationale Karrieremöglichkeiten
* umfassende Aus- und Weiterbildung
* aktive Gesundheitsförderung
* Gratis Parkplatz
* Kantine
* gemeinsame Firmenevents
Ihre Ansprechpartnerin:
Fresenius Kabi Austria GmbH
Frau Mag.Celina Gößler
Hafnerstraße 36
8055 Graz
www.fresenius-kabi.at
Senior Manager Regulatory CMC Biosimilars (m/w/d)
Ihr Aufgabengebiet
* For the assigned products/programs, define and execute an RA-CMC Strategy that best serves the biosimilars business needs and ensure compliance with regulatory requirements
* Plan, prepare and coordinate CMC related submissions with CMC and regulatory functions
* Track approval and provide regulatory input for changes implementation strategy in close collaboration with Quality, Supply and CMC functions
* As Business partner to the Biosimilar CMC team and Product Teams, represent the regulatory team in CMC and cross-functional forums
* Represent and defend the Company strategy in front of Health Authorities
* Manage externalization of RA-CMC activities as required
Wir erwarten
* Master's Degree in a Life Science or related discipline
* Between 5-8 years Regulatory Affairs CMC experience in a Biotech environment
* Experience with biological products, preferably Monoclonal antibodies (mAb)
* Experience in managing international regulatory submissions, BLA/MAA and LCM variations
* Experience with agency interactions
* Excellent spoken and written English. A second major language would be an advantage
* Excellent written and spoken communication skills
Wir bieten
* International challenges in a dynamic corporate environment
* Corporate social events
* Attractive performance-related salary package (annual gross salary starting at EUR 75.000,-, overpayment depending on occupational skills and experience)
JETZT BEWERBEN
Shortfacts
Einsatzort
Österreich/Deutschland
Ausmaß
Vollzeit
Eintrittsdatum
ab sofort
Anstellungsverhältnis
unbefristet
We are caring for our employees
* verlässlicher Arbeitgeber
* starkes globales Wachstum
* internationale Karrieremöglichkeiten
* umfassende Aus- und Weiterbildung
* aktive Gesundheitsförderung
* Gratis Parkplatz
* Kantine
* gemeinsame Firmenevents
Ihre Ansprechpartnerin:
Fresenius Kabi Austria GmbH
Frau Mag.Celina Gößler
Hafnerstraße 36
8055 Graz
www.fresenius-kabi.at
Senior Manager Regulatory CMC Biosimilars (m/w/d)
Ihr Aufgabengebiet
* For the assigned products/programs, define and execute an RA-CMC Strategy that best serves the biosimilars business needs and ensure compliance with regulatory requirements
* Plan, prepare and coordinate CMC related submissions with CMC and regulatory functions
* Track approval and provide regulatory input for changes implementation strategy in close collaboration with Quality, Supply and CMC functions
* As Business partner to the Biosimilar CMC team and Product Teams, represent the regulatory team in CMC and cross-functional forums
* Represent and defend the Company strategy in front of Health Authorities
* Manage externalization of RA-CMC activities as required
Wir erwarten
* Master's Degree in a Life Science or related discipline
* Between 5-8 years Regulatory Affairs CMC experience in a Biotech environment
* Experience with biological products, preferably Monoclonal antibodies (mAb)
* Experience in managing international regulatory submissions, BLA/MAA and LCM variations
* Experience with agency interactions
* Excellent spoken and written English. A second major language would be an advantage
* Excellent written and spoken communication skills
Wir bieten
* International challenges in a dynamic corporate environment
* Corporate social events
* Attractive performance-related salary package (annual gross salary starting at EUR 75.000,-, overpayment depending on occupational skills and experience)
JETZT BEWERBEN