Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell carcinoma. Our client's aim is to bring the first in class autologous cancer vaccine to the patients. To successfully drive the global regulatory strategy and execution of the lead candidate and additional pipeline candidates we are searching a driven and hands-on Director Global Regulatory Affairs: a hands-on RA-allrounder-personality with profound knowledge in driving global regulatory affairs from headquarters, preferably with experience in seeking EMA and FDA approval of tumor vaccines or cell-based therapies. You are the ideal candidate because of your pioneering mentality, your out of the box-thinking, your perceiving the big picture and because you are used to and ready to drive results in order to reach the goals. In particular to gain regulatory approval for the first in class autologous cancer vaccine in the pipeline. Director Global Regulatory Affairs (f/m/x) PhD and HQ-Can do-experience are requested Lead and develop regulatory strategy for the lead candidate and pipeline candidates Lead, improve and redefine regulatory strategy and activities for all areas of product development (pre-clinical, CMC and manufacturing and clinical) Drive in cross-functional execution and alignment Establish and execute all regulatory affairs related activities across functions focusing on Europe and USA Lead interactions with regulatory bodies including EMA and FDA Lead interactions with regulatory consultancy firms Degree in Life Science (PhD) Minimum of 10+experience in global regulatory affairs from HQs Experience in leading interactions with regulatory bodies including EMA and FDA Track record of successful filings of biologics, cell-therapies with EMA and FDA Background in immunology, vaccine development and / or cell therapies preferred Excellent communication and leadership capabilities High level English skills (oral / written) are requested Strong, mature, hands-on leader with convincing decision-making, negotiating, and influencing skills Driven teamplayer and individual performer according to needs, ready to work and to develop again in a dynamic biotech setting You are a bold, curious, goal-oriented, result and mission-driven, entrepreneurial-minded RA-professional equipped with strong analytical skills Open, dynamic and positive, diverse company culture with short decision-making and freedom to operate – offering an expert-context to set your individual footprint A meaningful position aimed at significantly improving the clinical outcome and quality of life for cancer patients Smart working

Zeig mehr