Senior Specialist, CMC Regulatory Affairs

Skills: 3 years of experience supporting Regulatory Affairs and/or CMC functions in the Biotechnology industry. Relevant experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development. Understanding of FDA regulations, and ICH GCP guidelines. Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills. Excellent attention to detail and demonstrated project management skills. Ability to work independently and collaboratively among cross-functional teams. Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities. Education: BA/BSc in a scientific field with a minimum of 5 years' experience; or MBA or MSc with a minimum of 2 years' experience

Created: 2026-04-02