Regulatory Toxicology Expert CDI H/F Bayer

Détail du poste

Develop into the following major tasks and responsibilities (under supervision of experienced colleagues and allowing for sufficient transition time) : BE globally responsible (supporting product activities in all regions - Asia, North & South America, Europe/Middle East/Africa) within Regulatory Toxicology for assigned active substances (e.g. completeness and quality of data, end point determination, state-of-the art human health assessments). Gain / maintain a sound awareness of international regulatory testing guidelines, requirements and criteria and follow new developments, policies and global trends. Ensure that all (guideline/non-guideline) studies required for global registration / re-registration of products are initiated on time and meet all requirements of relevant regulatory authorities. Where relevant, act as Study Monitor and provide GLP compliant reports. Provide planning, scheduling and cost estimates to global regulatory or project managers for all function relevant studies and track their progress; solicit input from regulatory toxicologists in the regions as appropriate; and track study progress, keeping regions informed of any issues and results. Develop a knowledge and ability to incorporate leading edge toxicology into testing strategies and dossier development. Collaborate with external consultants, academia, regulators and CROs. May include, supervision of assistants and external collaborators. Develop toxicology strategies and work programs, contribute to a wide range of issues, and act cross-functionally to effectively achieve Key Tasks : global alignment (all regions and all associated product/project stakeholders). Participate as the expert representative in interdisciplinary projects and BE accountable for the regulatory toxicology strategy in the context of achieving and maintaining registrations for assigned active substances and products. Present toxicological risk assessments in internal working groups or to regulatory authorities. Value Added : Anticipate compound related issues and proactively minimize negative effects in the areas of toxicology and human risk assessment. Negotiate with sponsors the specific needs in terms of toxicology studies, proposing the best possible solutions (deadline, quality, cost). Ensuring the follow-up of expenses associated with the work performed. Continuous quality and process improvement in Toxicology as related to regulatory success and time to market. Support from Regulatory Toxicology Experts is of fundamental importance in achieving registration of new products and maintaining the registration of established products. Excellence in Regulatory Toxicology allows registrations to BE obtained rapidly and efficiently, reduces time-to-market and avoids the loss of existing uses. Scientists (PhD or graduate) in relevant discipline (or related area), with several years of experience in area of expertise or adequate professional experience. Fluent in English (written and oral). * Excellent communication and negotiation skills; influencing and problem-solving. Ability to work in teams across multiple regions (cultural awareness). * Basic knowledge of national, European and international regulatory guidelines, criteria and processes. * Basic understanding of risk assessment and related disciplines in Regulatory Science (e.g. metabolism, operator exposure, environmental safety, residue analysis and dietary safety). Capacity to propose innovative solutions to potential issues and demonstrated flexibility and openness in approach and thinking