Eligo Bioscience mission is to develop treatments and cures for serious diseases in immuno-inflammation, oncology and infectious diseases.
Backed by top-tier investors from Silicon Valley and Europe, Eligo is an industry-leading biotechnology company, co-founded by scientists and professors from MIT and the Rockefeller University – now operating in Paris, France. We are progressing next-generation precision medicines through in vivo gene editing of the microbiome.
Our pioneering work in the field of synthetic biology has enabled Eligo to be elected as one of the 30 Most Innovative Companies by the World Economic Forum, to receive multiple prestigious international awards. We have also been featured in international media and scientific journals such as Nature Biotechnology, Science, The Economist, The BBC and The New York Times.
Eligonauts are driven, passionate, and motivated to impact the lives of patients by applying cutting-edge science to solve real unmet needs. We are at a very exciting point in time of the Eligo journey as we are embarking on the transition from a start-up deeply rooted in innovation to a clinical stage biotech with the objective to bring our lead program to the clinic within the next two years. We are therefore building a development team, in which the regulatory affairs and quality manager will contribute in a significant manner.
Eligo Bioscience has attracted highly-diverse top talent from all over the world, who are driven, passionate, and motivated to impact the lives of patients by applying cutting-edge science to save lives and treat chronic disease. Eligo embraces diversity, equal opportunity and inclusion and is committed to building diverse teams.
YOUR MISSION
At Eligo Bioscience, we are passionate about developing new drugs to address unmet medical needs! We are looking for a high-performing and enthusiastic Regulatory Affairs and Quality manager to support our most advanced program, EB005 in moderate-to-severe acne, into the clinic while developing a deep understanding of the regulatory specificities and challenges of Eligo pioneering modality. We believe that our lead asset EB005 has the potential to drastically reduce the disease burden, and as a Regulatory Affairs and Quality manager, you will foster productive conversations with regulatory agencies to support its entry in the clinic. You will also enable Eligo to become a clinical stage company by setting up the appropriate quality and regulatory policies.
POSITION SUMMARY
The Regulatory Affairs and Quality manager is responsible for the strategy and implementation of the regulatory and quality plan for the EB005 program and for supporting our earlier pipeline. He/she is accountable for the effective and timely discussions with regulatory agencies to ensure EB005 program moves swiftly to the clinic, including implementing the necessary quality system. In this vital role, the Regulatory Affairs and Quality manager will build and document Eligo regulatory knowledge and quality systems to support EB005 and to pave the way for how Eligo will develop new programs from its technology platform.
RESPONSIBILITIES
- Plan and manage regulatory submissions (scientific advice and pre IND meetings, clinical trial application) for EB005
- Develop and/or implement innovative and compelling regulatory strategies designed to support swift progression of EB005 program to the clinic
- Lead the development of regulatory documents and meetings
- Provide operational and strategic regulatory input to cross-functional teams for global projects
- Continuously evaluate the timelines and regulatory impacts in the overall projects, identify and mitigate regulatory risks and support contingency planning
- Collaborate with external CROs when applicable
- Develop and enforce the necessary GCP-related quality system (policy, SOPs) to support the company progression to clinical stage
APPLICANT PROFILE
- Advanced degree in a life-science discipline, ideally a PhD or PharmD with >3 years of experience in Regulatory Affairs
- In-depth understanding of the drug development process from a Regulatory perspective
- Experience in gene therapy, microbiome therapies or more generally advanced therapies is a plus
- Experience in early phase trials (Phase I-II) is strongly preferred.
- Knowledge of quality system and/or interest in learning with support from consultants. Experience managing or implementing a quality system is a plus.
- Previous experience or qualifications in microbiology, dermatology or immunology is a plus.
- Ability to understand and communicate scientific/clinical information
- The person is meticulous and rigorous about his/her work, has scientific honesty and ethics. Works well with others in the team.
- Fluent in English and strong verbal & written communication skills are a must.