Director Global Regulatory Affairs

vor 1 Woche

Vienna, Österreich Talentor Austria GmbH Vollzeit

Are you ready for the next step in your career? 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
YOUR FUTURE ROLE 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

JOB REQUIREMENTS 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

OUR CLIENT OFFERS 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


ARE YOU INTERESTED? If you are interested in this new, unique and exciting challenge, we look forward to receiving your online application via our career portal.

Our consultant responsible for you, Mag. Birgit Wandrak ( ), will contact you immediately after the receipt of your documents.

We kindly ask you to support us in processing your documents in accordance with the GDPR and to refrain from sending an e-mail application.


Location:
Vienna

Apply now

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