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

Fresenius Kabi Austria, with headquarters in Graz and 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.

• Einsatzort:
  Österreich/Deutschland
• Ausmaß:
  Full-time
• Eintrittsdatum:
  ab sofort
• Anstellungsverhältnis:
  unlimited

• Reliable employer
• Strong global growth
• International career opportunities
• Comprehensive education and training
• Homeoffice
• Jobticket
• Active health promotion
• Free parking space
• Bikeleasing
• Canteen
• Joint company events

Fresenius Kabi Austria
Frau Mag.Celina Gößler
Hafnerstraße 36
8055 Graz

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 € 75.000,-, overpayment depending on occupational skills and experience)

• Reliable employer
• Strong global growth
• International career opportunities
• Comprehensive education and training
• Homeoffice
• Jobticket
• Active health promotion
• Free parking space
• Bikeleasing
• Canteen
• Joint company events