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

at  Fresenius Kabi Austria GmbH

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

• 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