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  • 1 month ago

jobs 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.

Job Summary

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?
Our Regulatory Affairs department, on of it’s kind within Charles River is organized in two sections:
Regulatory Environmental Toxicology and Chemistry and Regulatory Toxicology.

For the first section we are looking for a new colleague

within the regulatory field

About 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 service, but also consultancy on the right testing strategy, hazard or risk assessments, support with submission or peer-review.
In addition, our regulatory affairs services also provide support with the preparation of expert statements/opinions, weights of evidence and study waivers fit for regulatory submission, as well as writing of manuscripts for publication in scientific journals.

About the team:
Our international working team performs regulatory support for our global chemical, agrochemical, biocidal and pharmaceutical clients. The flexible, integrated regulatory affairs team supports our clients on different regulatory frameworks.
Our subject-matter experts guide clients in their registration process and support interactions with regulatory authorities with the ultimate goal to bring new products to the market.
You work in a team of regulatory affairs experts as well as with colleagues from other Charles River departments.

About your roll:
As a Regulatory Chemist you will combine your knowledge on physical chemical properties, analytical data on e.g. substance identification and/ or residues with at least one legislative framework (i.e. agrochemicals, biocides or industrial chemicals) at a challenging level, while being part of an enthusiastic team.
We want you to do what you are good at, can get better at and would like to grow in.

Your activities include, depending on your interests, knowledge and experience:
• Evaluation and assessment of all aspects of chemistry data;
• Compilation of dossier parts focused on analytical data (e.g. residue methods and substance identification data), physical chemical data and technical product data for different legal frameworks (i.e. agrochemicals, biocides and/or industrial chemicals);
• Advising clients on regulatory aspects as well as on generation of data in the field of chemistry;
• When necessary and/or interested, coordination of projects for biocides, agrochemicals or industrial chemicals;
• Working closely together with your own regulatory team members, our study directors, sales and client services team, as well as staying in contact with clients and authorities;
• Presenting at (inter)national conferences.

Job Qualifications

Your profile:

• Relevant academic training, focusing on (analytical) chemistry;
• Knowledge of state of the art analytical techniques;
• At least 3 years of experience in a relevant field;
• Knowledge of the legal framework for the authorization of biocides, agrochemicals or industrial chemicals;
• You have good communicative skills, both oral and written, in English and in Dutch (B2);
• You are a team player with a pro-active, 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 at our Den Bosch office.

Other excellent primary and secondary terms of employment including:

• 27.5 vacation days and 2 collective days per year;
• Possibility to purchase 10 additional vacation days per year;
• Annual one-time 8% vacation pay of your gross annual salary;
• Annual one-time payment based on company results;
• Travel allowance at € 0.23 cents per kilometer with a maximum of € 250 net per month, or an NS Business Card;
• Company fitness with access to 400 locations with 1 subscription;
• Bicycle (lease) plan;
• Collective pension with a personal contribution of 2.9%;
• The possibility to play sports with colleagues on our own sports field;
• The possibility of a consultation with our in-house ergonomist;
• Free fresh fruit every day in our cafeteria.

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 supported the development of 86% of the drugs approved by the FDA in 2021.

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.

Job Segment: Pharmaceutical, Research Scientist, Chemical Research, Laboratory, Scientific, Science, Engineering
Leiden Netherlands


Apply - Regulatory Chemist Leiden