Job Description
Regulatory Specialist in Toxicology Dublin
Our client is a highly ambitious world leader in the development and registration of plant protection products and is well on their way to becoming the most successful agrochemical innovator ever. This is a rare opportunity for a bright, high achieving scientist to gain exceptional career development opportunities leading to excellent career advancement prospects. Our clients company culture is based on shared leadership and coupling responsibility to expertise, creating a flexible, collaborative environment for a uniquely rewarding and enjoyable work experience.
A key part of their highly ambitious global growth plans includes the expansion of their R&D pipeline. Ongoing growth of their product portfolio and the continual defence of existing product authorisations have led to a number of exciting opportunities in their Regulatory team for scientists who wish to put their knowledge and training to use in a fast-paced, results-focused commercial R&D environment. The main responsibility of this role will be assisting with the defence of existing product authorisations through the renewal process, including
Job Spec
- Classification of plant protection products by calculation according to Regulation (EC) 1272/2008
- Conducting risk assessments for operators, consumers, bystanders and residents using EU and national models
- Design and troubleshooting of toxicology studies including acute toxicity, genotoxicity and dermal absorption
- Assessment of the toxicological relevance of metabolites in groundwater
- Provision of support to the regulatory team in assessing the toxicological relevance of impurities
- Data gap analysis for active substances and products
- Collation of information from various sources in order to prepare logical and coherent reasoned case arguments
- Compilation and review of draft registration reports, with a particular emphasis on the toxicology section
- Liaison with Member State regulatory authorities, consultants, CROs, test facilities and other internal departments (e.g. laboratory)
Person Spec
- Excellent academic record in a relevant scientific subject. A degree is essential, with a masters or PhD being an advantage
- 2-3 years’ experience in regulatory affairs, ideally within a plant protection industrial setting
- Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic
- Perform tasks in an accurate, timely and efficient manner
- Excellent attention to detail is a must
- Ability to work on own initiative or as part of a team, in meeting strict timelines
- Excellent organisational skills with the ability to multi-task and work in an environment with shifting priorities
- Proactively seek to add value to processes, both existing and new
- Performance driven, with a 'can-do' attitude
- Proficiency in Microsoft Word, Excel, PowerPoint.
- Proficiency in an EU language (French/German/Spanish/Italian) would be an advantage