- Regulatory Lead for assigned Oncology CAR T cell pipeline projects;
- Develop and implement innovative global regulatory strategies for assigned projects;
- Provide guidance to team on Regulatory CMC, Nonclinical and Clinical topics;
- Develop detailed regulatory project plans and timelines for assigned projects; identify critical path activities, risks, gaps and mitigations;
- Manage regulatory submissions and rapid responses to Health Authority questions according to required timelines; coordination with internal and external collaborators;
- Liaise with individual contributors and Subject Matter Experts to develop key messages and complete regulatory submission documents;
- Write, prepare and review well-organized, scientifically sound regulatory documents;
- Format submission-ready documents to meet eCTD publishing requirements;
- Track submissions, archive correspondence, and maintain regulatory documentation;
- Maintain knowledge of current regulatory landscape and competitive intelligence;
- Review and interpret regulatory, clinical, scientific and other technical documents;
- Contribute to new internal documentation, SOPs and checklists as assigned;
- Additional support with department and company objectives as assigned;
- Masters in Pharmaceutical/Life Sciences with 5 years in a biopharma regulatory role or PhD in Pharmaceutical/Life Sciences with 3 years in a biopharma regulatory role;
- Expertise in Immuno-Oncology and Advanced Therapy Medicinal Products;
- Experience in eCTD-compliant regulatory submissions;
- Experience working within a Quality Management System (GxPs);
- Knowledge of European, US and International laws, regulations and guidelines for biologics and human cells and tissues.
- Fluent English (written and spoken), additional languages are an asset.
For more information please contact me at: +31 (0)20 20 44 502 or firstname.lastname@example.org.