At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

Head of Regulatory Affairs

Job Summary

We are recruiting for a Head of Regulatory Affairs for our Safety Assessment site located in Den Bosch, the Netherlands.
The regulatory affairs team performs regulatory support for our global chemical, agrochemical and pharmaceutical clients. The flexible, integrated regulatory affairs team supports our clients on different regulatory frameworks. 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. 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/or keep existing products on the market.

Your responsibilities:

As the Head of the Regulatory Affairs team, you lead the team and you are responsible for both the quality and structure of the team as well as the revenue generated by the department. With support of two section heads that report to the Head of Regulatory Affairs, you develop the department and the team members through coaching and support. Together with business development you take the initiative to establish and maintain collaborations with new and existing customers and you promote our capabilities to (potential new) clients. You work with other senior managers to identify new business opportunities.
In addition, you actively participate at (international) conferences and meetings where you present our work and expand our network. You are the key interface between the department and the large Charles River community both within the site as across our safety assessment network. You actively contribute to and support our site and global strategy.
You will be a member of the site management team and report to the Site Director.

Your profile:

• Masters degree in life science
• At least 3 years of experience in managing a (Regulatory affairs) team
• At least 5 years Regulatory Affairs experience in at least one of the relevant legislative frameworks (agrochemicals, biocides, industrial chemicals, pharmaceuticals)
• Commercial and client focused mindset, with respect for science
• Excellent communication, both oral and written, in Dutch and English
• You are an inspiring and enthusiastic people leader and an excellent coach
• You are structured and well organized
• Ability to define clear expectations and set ambitious but achievable goals
• Relevant scientific education and experience in a field such as toxicology, pharmacology, biology, environmental sciences
• Willing to work mainly on site in Den Bosch, the Netherlands

Our offer:

Working at our organization means working in a dynamic international organization. In addition, we offer excellent primary and secondary working conditions 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;
• Training and development opportunities;
• Company fitness membership;
• Travel allowance at € 0.23 cents per kilometer with a maximum of € 250 net per month, or an NS Business Card;
• 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;
• A challenging position in a global company;
• A high skilled and motivated team of more than 25 regulatory specialists;
• An open business culture and a pleasant, informal atmosphere.

If you are interested in this position, we invite you to apply via our career site Charles River Laboratories, Inc. Jobs (criver.com) Do you have any questions about this vacancy? Please contact Petra Brondgeest at + 31736406700.

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 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.

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.