Regulatory Affairs specialist

Universität Zürich

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  • Publication date:

    31 January 2024
  • Workload:

    80 – 100%
  • Contract type:

    Temporary
  • Language:

    German (Fluent), English (Fluent)
  • Place of work:

    Zürich

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 are a young and dynamic preclinical stage startup focused 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. We are looking for someone to join our team who is passionate about our mission and can supplement the inclusive and open culture we aim to foster as we continue to grow.

Regulatory Affairs specialist

Wyss Zurich Translational Center

Regulatory Affairs specialist

80-100 %

Your responsibilities

  • Strategic management of quality and regulatory topics for Recolony's portfolio of Live Biotherapeutic Products (LBPs) and small molecules
  • 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 & meetings
  • Ensure CMC compliance of outsourced activities with 3rd party vendors supporting production of live biotherapeutic products

Your profile

  • Master degree or PhD in life sciences
  • Minimum 5 years' regulatory experience in pharmaceutical/biologic drug development with strong GxP working knowledge
  • 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
  • Willing to work physically in Zurich

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.

Place of work

Start of employment

Employment start date to be mutually agreed or preferentially April 1, 2024. Please submit your application by 29/02/2024.

Further information

Write an email

Contact

  • Universität Zürich

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