Director Global Regulatory Affairs

vor 4 Wochen

Wien, Österreich Talentor Sweden AB Vollzeit

**Director Global Regulatory Affairs (f/m/x)**:
**PhD and HQ-Can do-experience are requested**:
***YOUR FUTURE ROLE**:

- 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?**:

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