Recolony – Switzerland

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.
At Recolony, we focus our efforts on understanding and leveraging the beneficial effects of the human microbiota. The bacteria of the intestinal microbiota have an enormous influence on our immune system and are able to provoke and enhance an effective immune reaction against cancer. By harnessing the potential of beneficial gut microbiota, Recolony aims to develop a completely new class of drugs for the treatment and prevention of cancer.
Your responsibilities
Strategic management of quality and regulatory topics for Recolony
Drive the development and continuous improvement of a quality management system and drive adoption within Recolony
Ensure compliance with all applicable standards and regulations
Main point of contact for authorities 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 & meetings
Ensure quality of outsourced activities with 3rd party vendors i.e. production of live biotherapeutic products in accordance with cGMP requirements
Your profile
Master degree or PhD in life sciences
Minimum 5 years’ regulatory experience in pharmaceutical/biologic drug development with strong GxP working knowledge
Experience in QMS development
Prior successful filing IND/IMPD within timelines
Experience with microbiota and live biotherapeutics is preferred
Outstanding interpersonal skills with excellent communication capabilities for liaising with various internal and external stakeholders
Fluent spoken and written English. Good command in German is an advantage.
Good team player: ability to work both independently and collaboratively within the team
Deadline-driven: commitment to planning, coordinating and meeting regulatory timelines
Comfortable in a high growth environment that requires proactive engagement.
Time management: managing the time effectively to handle multiple responsibilities
Quality-focused: a strong understanding of quality standards and a dedication to developing functional quality systems are essential
What we offer
This is a unique opportunity to join a young, dynamic and growing start-up team developing tomorrow’s treatment against cancer. You will benefit from an inspiring and socially relevant environment.