Project Manager, Regulatory Affairs (Biotechnology/Biomedical Products) | Pharmacist (m/w/d)
INM - Leibniz-Institut für Neue Materialien gGmbH
Job Summary
This role seeks an experienced Project Manager to lead a high-visibility, community-driven initiative focused on Engineered Living Materials (ELMs), a crucial area at the intersection of materials science and synthetic biology. The successful candidate will coordinate the MaterialVital Hub, a knowledge-exchange network linking diverse stakeholders, including academic institutions, industry partners, consultants, and regulatory agencies. Key responsibilities involve establishing and expanding this expert network, conceptualizing information exchange formats, and systematically analyzing existing regulatory frameworks relevant to ELM development (e.g., EU GMO, MDR, ATMPs). A primary goal is the elaboration of praxis-oriented guidelines, decision-making trees, and metrics for safe-by-design approaches. This position offers substantial room for creativity and career development within an international research environment, requiring a Master’s degree in Regulatory Affairs or a related science field, proven project management skills, and strong communication abilities in both German and English.
Required Skills
Education
Master’s degree in Regulatory Affairs or University degree in natural, engineering or life sciences. A PhD in biomedical materials, microbiology, or experience in clinical translation of cell therapies is considered beneficial.
Experience
- At least 2 years of related work experience in Regulatory Affairs (if holding a Master’s degree in Regulatory Affairs)
- Several years of experience in regulatory science or regulatory affairs (if holding a university degree in natural, engineering, or life sciences)
- Experience in regulatory frameworks relevant to biotechnology and biomedical products (e.g., EU GMO regulation, medical device regulation (MDR), ATMPs)
Languages
Additional
- Initial contract duration of 3 years. Structured working style required.
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