Introduction

The INM-Leibniz Institute for New Materials is an internationally leading center for interdisciplinary research on materials, and their exploitation in materials-based solutions for a sustainable world with increasing digitalization and medical needs. Our research integrates materials chemistry, biological processes, physical analysis, process engineering and data science. We collaborate with academic and industrial partners all around the world.


A focus of our research are Engineered Living Materials (ELMs), an emergent class of materials at the interface between materials science and synthetic biology, with huge potential for sustainable innovation in different technological and medical fields. Our institute develops safe-by-design concepts for responsible ELM innovation.

To lead a community-driven initiative in ELMs, we seek a


Project Manager in Regulatory Affairs related to biotechnology/biomedical products (f,m,d)



to develop guidelines and best practices for the development of safe and sustainable ELM-based technologies in the future. The project manager will coordinate a knowledge-exchange network that links multiple stakeholders (academic institutions, industry, consultants and regulatory agencies) and experts with interest in ELM research, innovation and regulation. This project is framed within the collaborative network MaterialVital Hub, recently funded by the Federal Ministry of Research, Technology and Space (BMFTR).

Establishment and expansion of a network of experts to include relevant stakeholders in ELM research and innovation, as well as regulatory experts. Communication and coordination of the work within the network.
Conceptualization and implementation of information exchange and documentation formats within the network.
Analysis of needs, challenges and upcoming expectations for ELM regulation through interviews and dedicated workshops with experts.
Systematic analysis and documentation of existing frameworks of relevance for ELM regulation.
Elaboration of praxis-oriented guidelines, decision-making trees and proposing metrics for safe-by-design approaches in ELM development. These should be informed and compile the knowledge from the exchange among experts in the network.
Conceptualization of the outreach action plan (website, online platform, workshops) in cooperation with scientists in MaterialVital Hub and communication experts at INM and partner institutions.
Reporting to project coordinator, partners and funding agencies.

Master’s degree in Regulatory Affairs and at least 2 years of related work experience. Alternatively, university degree in natural, engineering or life sciences and several years experience in regulatory science or regulatory affairs. A PhD in biomedical materials, microbiology, or experience in clinical translation of cell therapies is considered beneficial.
Experience in regulatory frameworks relevant to biotechnology and biomedical products (e.g. EU GMO regulation, medical device regulation (MDR), ATMPs) is highly desirable.
Strong analytical skills and attention to detail.
Clear writing and strong communication skills in German and English.
Project management and organization skills. Structured working style.

An interesting and timely topic with high visibility, as well as opportunities for interaction with public and private partners.
A network of interested and collaborative partners to support your work.
A dynamic environment with substantial room for creativity, profile and career development.
A professional and supportive working environment with an open and international culture.
A well structured on-boarding process and clear responsibilities.
Possibilities for further training and qualification.
Flexible working hours and mobile working opportunity.
A family-friendly working place.
A EG 13 TV-L position (full time). A part time position is also possible.


The position is initially for 3 years.