Regulatory and Quality Assurance Specialist 80
vor 4 Wochen
80-100 % The Wyss Zurich Translational Center (Wyss Zurich) is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss Zurich is to drive the clinical translation and technology transfer of outstanding scientific discoveries into new therapies for patients and breakthrough innovations in the emerging fields of Regenerative Medicine and Robotics, and to promote hybrid technologies in these fields. Wyss Zurich brings together some of the world's leading experts to form multidisciplinary teams, pooling their knowledge and expertise.
Project Phire is a young biotechnology startup poised to initiate a groundbreaking first-in-human trial with a novel bispecific T cell engager. Embedded within the Wyss Zurich accelerator, we are driven by innovation and a commitment to revolutionize the treatment landscape for acute myeloid leukemia and other blood diseases through cutting-edge immunotherapies. Your responsibilities We are seeking a highly skilled Regulatory and Quality Assurance Specialist with a robust background in clinical trials of immunotherapies. The ideal candidate will possess extensive experience in navigating regulatory pathways, particularly with submissions to regulatory bodies such as the FDA, EMA, and possibly an understanding of PEI guidelines. This individual will play a pivotal role in ensuring compliance, driving regulatory strategy, and overseeing quality assurance measures for our early-stage clinical trials.
Key Responsibilities:
- Strategic management of quality and regulatory topics. Develop and implement regulatory strategies in alignment with company goals, focusing on early-stage clinical trials for novel immunotherapies.
- Ensure compliance with all applicable standards and regulations.
- Main point of contact for authorities (FDA, Swissmedic, PEI, etc) in all regulatory topics including the preparation, submission and management of regulatory documents and submissions.
- Communicate and coordinate with external consultants.
- Participate in key regulatory conferences and meetings.
- Establish and maintain quality assurance systems, overseeing processes to ensure adherence to GxP regulations.
- Monitor and interpret evolving regulatory requirements, providing proactive recommendations to mitigate risks and optimize regulatory processes.
- Bachelor's or Master's degree in a relevant scientific discipline. Advanced degree preferred.
- Minimum of 5 years of hands-on experience in regulatory affairs within the biotechnology or pharmaceutical industry with strong GxP working knowledge
- Proven track record of successful submissions to FDA/EMA within timelines
- In-depth knowledge of early-stage clinical trial requirements and processes.
- Experience in immunotherapy, antibody technologies preferred.
- Strong understanding of quality assurance principles and regulatory compliance frameworks (GxP, ICH guidelines).
- Exceptional written and verbal communication skills in English; proficiency in additional languages, especially German, is a plus.
- Deadline-driven: commitment to planning, coordinating and meeting regulatory timelines.
- Ability to thrive in a dynamic, fast-paced startup environment and contribute effectively within a multidisciplinary team.
- Enthusiasm, adaptability, and a proactive mindset to drive innovation and compliance in a challenging and evolving regulatory landscape.
Diversity and inclusion are important to us. Place of workWeinbergstrasse, Zürich, Switzerland Start of employment Employment start date to be mutually agreed, preferrably as soon as possible. Please submit your application by 15/04/2024.
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