Austria Job Openings

Fresenius Kabi Austria GmbH

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

Graz

September 19, 2024

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 (m Ab)
  • 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
Fresenius Kabi Austria
Frau Mag.Celina Gößler
Hafnerstraße 36
8055 Graz

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