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 Toxicologist

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 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 Qualifications

Your 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.