Job Description: We are seeking an experienced regulatory toxicologist as a Product Safety Toxicologist for our global Regulatory Affairs organization. The position will be based at our division's headquarters in The Woodlands, Texas, is office-based, and has the option of working a hybrid office/remote schedule. The Product Safety Toxicologist will report directly to the Regulatory Affairs Director.
What will be expected from you? - Provide regulatory toxicology assessments on new and existing substances/products in global regulatory venues.
- Guide discussion about development of safer and more sustainable products, providing support to New Product Introduction Teams about hazard reviews and additional testing needs.
- Ensure accurate and documented Hazard classification for each portfolio and pipeline products.
- Responsible for conducting and managing Ecotoxicological and Toxicological studies performed with Indorama Oxides and Derivatives (IOD) products.
- Support the CAS & Composition Committee - for Pipeline and Portfolio - a multifunctional team accountable for defining product composition details.
- Lead the Toxicological & Ecotoxicological Testing Committee - for Pipeline and Portfolio - a multifunctional meeting accountable for defining the best strategy to maximize safety information availability with minimum use of animal tests and ensuring financial feasibility.
- Support chemical registration activities to ensure outsourcing of any toxicological/ecotoxicological studies, including choice of laboratory, is undertaken appropriately. Make suitable business recommendations, perform protocol reviews, approve protocol amendments, monitor the conduct of the studies, assess raw data, and review draft and final study reports to ensure optimal study results, this minimizing business impact.
- Respond to customer inquiries regarding toxicology and risk assessments for substances/products.
- Lead Exposure Risk Management process implementation by reviewing product hazards versus evaluating all potential exposures based on each product application of use.
- Develop Safety reports required by the Government or by customers.
- Ensure general business support by providing product safety awareness to local and global businesses.
- Ensure good integrity of physical chemical properties, toxicological, and environmental fate, and effects data.
- Execute the product safety pilar of the Sustainability program by conducting risk assessments of hazardous products for the product pipeline and portfolio.
- Develop and encourage use of in silico tools and read across inputs reducing the number of IN VITRO & IN VIVO tests and increasing safety knowledge about each commercialized product.
- Take initiative to proactively encourage cross-functional support and relationships to address regulatory requirements in all business meetings, plans and objectives. Establish collaborative connections among different areas of the company through the activation of ad hoc multifunctional committees or informal networking meetings.
- Establish a supportive partnership with all regulatory affairs team members by attending internal meetings, following global procedures, and sharing information.
- Conduct training sessions using digital and user-friendly tools to simplify interpretation and communication of the product safety subjects.
- Maintain and develop technical expertise in areas of toxicology and risk assessment. Keep abreast of relevant regulations, legislation and emerging issues related to chemical hazard and risk assessment. Interpret and inform the impact to the relevant business(s).
- Develop and foster relationships with internal corporate support functions and with external agencies/groups to discuss future regulations and present comments to propose regulations.
- Represent Indorama in various product/chemical safety industry and trade associations (e.g., ACC, ACI). Advise and convey relevant information to stakeholders which could influence or impact Indorama operations.
What are we looking for in the ideal candidate? Requirements: - Undergraduate degree in a scientific discipline with a strong organic chemistry component.
- Solid knowledge and experience with OECD guidelines and with alternative method regulations to avoid use of animals.
- Expertise using several IN SILICO tools.
- Proven and successful experience of using read across to support product safety.
- Extensive and in-depth assessment of the literature and databases, searching and evaluating all data gathered.
- A proven track record (5+ years) of successfully managing safety evaluation of chemicals.
- Very skilled at interpreting regulations and extracting the potential business implications.
- Excellent communicator, verbal and written, with a very good command of the English language.
- A strong team player mentality.
- Open minded, eager to learn from others.
- Exceptional critical thinking skills.
- Able to manage and coordinate multiple projects and consistently deliver results on time.
- You receive and give feedback comfortably, gracefully.
- A quick study, always learning, adding new skills.
- Occasional travel (