Senior Manager Regulatory CMC Biosimilars (m/w/d)

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

Graz

Vollzeit

ab sofort

unbefristet

• verlässlicher Arbeitgeber
• starkes globales Wachstum
• internationale Karrieremöglichkeiten
• umfassende Aus- und Weiterbildung
• aktive Gesundheitsförderung
• Gratis Parkplatz
• Kantine
• gemeinsame Firmenevents

Ihre Ansprechpartnerin:

www.fresenius-kabi.at

Senior Manager Regulatory CMC Biosimilars (m/w/d)

• 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

• 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

• 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