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.
Shortfacts
- Einsatzort:
Österreich/Deutschland - Ausmaß:
Full-time - Eintrittsdatum:
ab sofort - Anstellungsverhältnis:
unlimited
We are caring for our employees
- 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
Ihre Ansprechpartnerin
Your contact person
Fresenius Kabi Austria
Frau Mag.Celina Gößler
Hafnerstraße 36
8055 Graz
karriere-fresenius-kabi.at Senior Manager Regulatory CMC Biosimilars (m/w/d)
Your tasks
- 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
Our expectations
- 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
We offer
- 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)
We are caring for our employees
- 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
