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Wil je zoals deze

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about

 
The Regulatory Affairs Department is involved in all aspects of the preparation of dossiers for registration of substances for different legal frameworks, e.g. industrial chemicals, agrochemicals, biocides, pharmaceuticals. The department is currently organized in three sections: Regulatory Environmental Toxicology and Chemistry, Global regulatory Consultancy, and Regulatory Toxicology. For the latter section we are looking for a new colleague, a

 

TOXICOLOGIST within the regulatory field

As a Regulatory toxicologist you have knowledge of the specific safety studies (in silico, in vitro, in vivo) based on international guidelines for safety testing as required for registration. You will be involved in discussions on study results and regulatory interpretation with study Directors and Clients and/or with Regulatory Authorities. You prepare study summaries of (safety) toxicity studies (such as studies on acute and repeated dose toxicity, local toxicity, genotoxicity, reproduction and developmental toxicity) and perform risk assessments, including derivation of safety limit values and proposal for Classification and Labelling in registration dossiers. Other activities can include literature searches, the preparation of expert statements, read-across with analogous substances, and coordination/management of projects. You work in a team of regulatory affairs scientists and experts as well with colleagues from other Charles River departments. The aim is to make best use of your interest, knowledge, capabilities and wishes to grow, enabling best quality of services to our clients and work with your colleagues in a (highly) satisfactory way. 

Your profile:

• You have a relevant academic training, such as (medical) biology, (molecular) life sciences, toxicology, biochemistry;
• You have experience in the preparation of toxicological hazard assessments, derivation of human health limits values and preferably risk assessment;
• Preferably knowledge of at least one of the following legal frameworks: industrial chemicals, agrochemicals, biocidal and/or pharmaceutical legislation in order to understand the legal (safety) requirements for market approval;
• Chemistry knowledge and project management experience is a pre;
• You have good communicative skills, both oral and written, in English and in Dutch
• You are a team player with a pro-active, result oriented, enthusiastic, flexible, dynamic and critical attitude.

 

Our offer:

• A challenging job in an international working team;
• Office in Den Bosch, the Netherlands;
• To further develop within the fields of regulatory toxicology;
• A position for 32-40 hours per week;
• Good primary and secondary benefits;
• An open culture in a pleasant and informal atmosphere.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

 

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 
With over 14,000 employees within 80 facilities in 23 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.

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