Senior Regulatory Toxicologist

Job title:

Senior Regulatory Toxicologist

Company:

Charles River Laboratories

Job description

For 75 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.Are you looking for a varied job in an international working team? Bringing your knowledge and expertise together with other experts to come to a tailored support to our client needs?
Within the Section of Regulatory Toxicology in the Regulatory Affairs Department, we are looking for a new colleague:Senior Regulatory ToxicologistAbout the department:
Our regulatory affairs support is characterized by a tailored, case-by-case approach, depending on specific client needs. We provide full registration dossier services, but also consultancy on the right testing strategy, hazard and risk assessment, support with submission or communication with regulatory authorities and other stakeholders.
In addition, our regulatory affairs services also involve support with the preparation of expert statements/opinions, weights of evidence and study waivers fit for regulatory submission, and writing of manuscripts for publication in scientific journals.About the team:
Our international working team provides regulatory support for our global chemical, agrochemical, biocidal and pharmaceutical clients.
Our subject-matter experts guide clients in their registration process and support interactions with regulatory authorities with the goal to bring new products to the market while ensuring their safe use and efficacy.About your roll:
As Senior Regulatory Toxicologist you will apply your knowledge on toxicology and human toxicological risk assessment within at least one legislative framework (i.e. pharmaceuticals/non-clinical safety, medical devices; agrochemicals, biocides and/or industrial chemicals) at a challenging level for you, while being part of an enthusiastic team. We want you to do what you are good at and want you to develop further, while sharing your knowledge and expertise to the benefit of our clients and your colleagues.Your activities may include, depending on your interests, knowledge and experience:

• Evaluation and assessment of all aspects of human toxicological data;
• Compilation of toxicology sections in dossiers for different legal frameworks (i.e. non-clinical parts of the dossier for pharmaceuticals; agrochemicals; biocides; industrial chemicals);
• Preparation of expert statements; literature searches; advice on testing strategy and data gap analysis;
• Use of in silico methods/NAMs for the assessment of various toxicological endpoints;
• Assessment of endocrine disrupting properties within EFSA/ECHA framework;
• Internal peer review and supervision of junior colleagues;
• Coordination of complex regulatory projects;
• Working closely together with your own regulatory team members, CRL study directors, sales and client services team, as well as staying in contact with clients and authorities;
• Presenting at (inter)national conferences and participating in internal and/or external working groups.

Job QualificationsYour Profile:

• Relevant academic training, focusing on toxicology, biology, life sciences and/or (bio)chemistry; ERT registration is a pre;
• High level of knowledge of at least one legal framework mentioned above (preferably non-clinical safety of pharmaceuticals);
• At least 5 years of experience in the field of regulatory toxicology; the ability to work independently and to peer review and supervise junior colleagues;
• Experience in at least one of the following topics will be considered as a strong benefit: knowledge and experience with the use of in silico methods (e.g. LHASA Nexus package, OECD QSAR Toolbox; VEGA; Toxtree etc.); knowledge and experience with non-clinical (safety) testing and ICH guidelines; knowledge and experience with impurity qualification in pharmaceutical drug products; knowledge and experience with the assessment of endocrine disrupting properties under ECHA/EFSA framework; high level of expertise in a particular toxicological field (e.g. pharmacology; ADME; genotoxicity; reproductive and developmental toxicity; neurotoxicity; carcinogenicity);
• Experience in dealing with Competent Authorities is a pre;
• A basic background in chemistry is a pre;
• You are a team player with a pro-active, self-learning, result oriented, enthusiastic, flexible, dynamic and critical attitude.

Our offer:

• We offer a position for 32-40 hours per week in an open culture and informal atmosphere
• Working from home is allowed. Also foreign candidates from other EU countries are encouraged to apply;
• Working hours can be determined in consultation, so that an optimal work-life balance is possible.

Depending on your location, country-specific benefits may apply on our excellent primary and secondary terms of employment.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 300 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 20,000 employees within 110 facilities in over 20 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

Expected salary

Location

‘s-Hertogenbosch, Noord-Brabant

Job date

Fri, 18 Jul 2025 22:57:14 GMT

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