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.
Fresenius Kabi Austria
Frau Mag.Celina Gößler, MA
Hafnerstraße 36
8055 Graz
www.fresenius-kabi.at #J-18808-Ljbffr