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Company
Bayer Direct Services GmbHPlace(s)
Sophia AntipolisRegulatory Toxicologist (m/f), Sophia-Antipolis
Permanent
Engineering, sciences, health
Offer archived at 16/11/2018
Bayer Direct Services GmbH
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Missions
As Regulatory Toxicologist, you will 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, interpretation of data for use in hazard and 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 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.
Who you are
- You are Scientist (PhD or graduate) in relevant discipline with first experiences in area of expertise or adequate professional experience.
- You have excellent communication and negotiation skills. You are influencing and problem-solving and are able to work in teams across multiple regions (cultural awareness).
- Basic knowledge of national, European and international regulatory guidelines, criteria and processes is required as well as basic understanding of risk assessment and related disciplines in Regulatory Science (e.g. metabolism, operator exposure, environmental safety, residue analysis and dietary safety).
- You have the capacity to propose innovative solutions to potential issues and demonstrated flexibility and openness in approach and thinking.
- Fluency in English (written and oral) is mandatory.
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Offer archived at 16/11/2018
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