Regulatory Officer – reNEW Leiden

We are looking for a regulatory affairs specialist, who is ambitious and interested in the development of advanced therapies. Do you see yourself in this role? Apply now!

About your workplace
By joining our expanding regulatory team, you’ll become a vital member of a pioneering group. Our matrix structure ensures close collaboration with research teams, and you’ll be an integral part of this cross-functional approach. In our team, you will part reNEW Leiden. reNEW is an international research center focused on stem cell research and the translation from lab to clinic. Within this consortium, we work together with reNEW Copenhagen (University of Copenhagen, Denmark) and reNEW Melbourne (Murdoch Children’s Research Institute, Australia). There are around 240 employees working for reNEW Leiden, mainly in the laboratories. In addition, you will be closely affiliated with other (inter)national consortia such as Cure4Life and RECOMB.

Our focus is on developing therapies for rare diseases with significant unmet medical needs. The regulatory team is currently situated within the Staal group, renowned for developing the world’s first stem cell gene therapy for RAG1-SCID, which is now advancing through a phase I/II clinical trial. This role offers a unique opportunity to be at the vanguard of medical innovation, contributing to groundbreaking advancements and making a direct impact on patient care. Our goal is to efficiently translate scientific discoveries into affordable clinical applications, thereby bringing cutting-edge medical solutions to those who need them most.

About your role
In this role, you’ll advance technologies developed in LUMC through early development, focusing on quality and non-clinical development. Your pivotal role bridges the gap between academic researchers/clinicians and regulatory agencies, whose language you speak. Your expertise enables you to independently transform scientific data into regulatory documentation.

As a key member of the development team, you’ll plan and advance projects, applying your understanding of regulatory processes. You are responsible for drafting high-standard regulatory documents, ensuring scientific and regulatory compliance. Your scientific acumen should match that of the researchers. Your understanding of the regulatory landscape is crucial in developing a concrete plan to navigate new technologies or therapies through the translational and regulatory process. Your project management skills are essential in realizing these plans.

You’ll be central in the team’s efforts to steer projects through the regulatory landscape, aiming to reach the patients for whom the therapy is intended.

About you

  • You have a PhD in Life Sciences, such as (Bio)Medical Sciences, (Bio)Pharmaceutical Sciences, Pharmacy, or a similar scientific discipline. Candidates with a Master’s degree in Life Sciences with relevant work experience may also be considered.
  • Experience in drug development within a regulatory affairs setting, in a pharmaceutical/biotech company, regulatory consultancy, or an academic drug development context, or a strong background in R&D, with a successful history of advancing new technologies/therapies in a regulatory dense environment.
  • Knowledge encompassing all facets of product development, spanning research, clinical trials, manufacturing practices, regulations, and approval processes for pharmaceutical products and/or medical devices.
  • A strong biomedical background is vital, along with comprehensive knowledge of regulatory requirements, ideally in the Advanced Therapy Medicinal Products (ATMP) landscape.
  • Strong verbal communication and writing skills in English. Proficiency in Dutch is a bonus.
  • Solid understanding of scientific and technical documentation.
  • Ability to effectively collaborate across diverse disciplines and drive projects forward.

Interested or having questions? You can find more information and apply via the link below. Applications are open until March 14th.