Richard van der Linden, PhD, RAC
Principal QA/RA Consultant
Personal Profile
Seasoned analytical and strategic thinker, team player, trainer and coach in the areas of human tissues, cell therapies and medical devices, with track record of successfully implemented (international) certifications and pharmaceutical licensing trajectories. Strategic skills and contribute in defining effective regulatory, quality road maps leading to product approvals. Communicate on all different levels within international organizations and with Competent Authorities. Create something new, build, educate, grow companies and their people are my internal drivers.
Specializations
- Human Tissues (Responsible Person)
- Cell and Gene Therapy
- Pharmaceutical / Medical Device logistics
- GDP (Responsible Person)
- Biologicals, Vaccines, Blood products
- ISO13485
- Process analysis
- Supplier and internal Audits
- Training and Coaching
Certifications
- RAC-EU
- BSI certified ISO 13485 auditor
- Responsible Person Human Tissue
- Responsible Person GDP
RICHARD VAN DER LINDEN
Professional Experience
Principal Consultant Quality Assurance & Regulatory Affairs
Signifix | 2018 – present
Sr Consultant Quality Assurance & Regulatory Affairs
Signifix | 2011 – 2018
Consultant Quality Assurance & Regulatory Affairs
Signifix | 2006 – 2011
Director Operations
CatchMabs | 2005-2006
Senior Scientist Molecular Recognition
CatchMabs | 2003-2005
Scientist Haematological Tumour target discovery
Crucell |2002-2003
Scientist Human Therapeutic Antibodies
Crucell | 2000-2002
RICHARD VAN DER LINDEN
Academic Education
University of Utrecht , Faculty of Biological Sciences/ ID-Lelystad/ Unilever Research Laboratorium Vlaardingen:
PhD in Life Sciences Molecular Immunology | 1995 – 1999
Thesis: “Unique Characteristics of llama heavy chain antibodies” (ISBN: 90-646-4637-6)
University of Utrecht , Faculty of Biological Sciences
Master of Science, Molecular Cell Biology | 1989 – 1995
RICHARD VAN DER LINDEN
Publications
A number of publications in peer reviewed scientific journals, one patent, chapter 30 co-author in Fundamentals of EU Regulatory Affairs (7th ed.) and Joint replacement technology (2nd ed.)
