Your tasks
* For the assigned products/programs, define and execute an RA-CMC Strategy that best serves the biosimilars business needs and ensures compliance with regulatory requirements.
* Plan, prepare, and coordinate CMC-related submissions with CMC and regulatory functions.
* Track approval processes and provide regulatory input for change implementation strategies in close collaboration with Quality, Supply, and CMC functions.
* Act as a business partner to the Biosimilar CMC team and Product Teams, representing the regulatory team in CMC and cross-functional forums.
* Represent and defend the company's strategy before 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 of Regulatory Affairs CMC experience in a biotech environment.
* Experience with biological products, preferably monoclonal antibodies (mAb).
* Experience managing international regulatory submissions, BLA/MAA, and LCM variations.
* Experience with agency interactions.
* Excellent spoken and written English; proficiency in a second major language is an advantage.
* Strong 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, with potential overpayment depending on skills and experience).
We care for our employees
* Reliable employer.
* Strong global growth.
* International career opportunities.
* Comprehensive education and training.
* Home office options.
* Job ticket.
* Active health promotion.
* Free parking space.
* Bike leasing.
* Canteen facilities.
* Joint company events.
Fresenius Kabi Austria
Frau Mag. Celina Gößler, MA
Hafnerstraße 36
8055 Graz
www.fresenius-kabi.at
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