Toxicology and Biosafety
Senior RA Expert
DVM, PhD, MBA, Royal Veterinary and Agricultural
Available for: Tasks
- Regulatory toxicology and product safety.
- Biological Evaluation Report.
- Clinical Evaluation Report.
- Medical Writer.
- Biological Evaluation Plan and testing strategy.
- Toxicological exposure and safety assessment.
- Regulatory compliance for industrial chemicals, biocides and medical devices.
- Planning, execution and evaluation of biocompatibility and chemical characterization studies.
- Risk/safety assessment of chemicals, impurities, migrating substances etc.
- Specialist in toxicology and development of new medicines and biotechnological products.
- Publication of more than 60 peer-reviewed papers.
- Scientific writer/medical writer experience.
- Head of department of a group of 30 toxicologists.
- Development of toxicological courses at post graduate level.
- Submission of several non-clinical reports to authorities.
- Head of Danish group for development of ISO standards for safety evaluation nanoparticles.
- Danish representative at advisory board for EFSA.
- Preparation and leadership to ensure marketing of consumer products to markets in EU and USA.
Extensive knowledge in:
- ISO 10993 for biosafety of medical devices.
- Toxicological support for material selection or substitution projects.
- ICH guidelines for non-clinical testing for safety of biotech, pharma, medical devices, food and feed
ingredients and foods.
- International submissions and approvals in: EU (EMA, EFSA, ECHA), FDA, Health Canada, China.
Is a pragmatic, enthusiastic, extrovert, resourceful, constructive and straight forward person that believes in an open and honest dialogue, and enjoys working with others.
He has many years hands-on experience in Regulatory Affairs in relation to the non-clinical area and has been working with many different products.
He spends his free time with family, friends, biking, running and reading novels.