214 Toxicology Jobs - Page 8

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Teach forensic medicine to medical students, interns, and residents. Conduct research in forensic sciences, including forensic pathology, toxicology, and forensic anthropology. Participate in forensic investigations, including autopsy examinations Required Candidate profile We are looking for Senior Resident, Assistant Professor, Associate Professor and Professor in the Department of Forensic Medicine. Relevant Experience candidates will be given more preference.

Key Responsibilities Learning the operations of Analytical Instruments under the guidance of mentor. Learning the new Analytical Techniques used in Analytical Research Department. Coordination with Synthesis and other cross-functional departments. To ensure Good Laboratory & safety practices in the lab. Participate in ARD SOP trainings and other departmental trainings (Quality Assurance & EHS, HRD etc.) as and when required. Basic knowledge of instrumental technique with its application. analytical chemistry (HPLC/LCMS/NMR or purification) Person Profile Qualification: - M. Sc (Analytical Chemistry) Experience: - 0 years Any kind of internship or course work done at some Industry or reputed institute

Essential Duties and Responsibilities. Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support trace analysis projects and change control activities. Collaborate with a multidisciplinary team of subject matter experts (e.g. E&L, Materials, Biocompatibility, and Toxicology) to develop trace analysis strategies that align to regulatory requirements for medical devices and drug products. Participate in E&L change control impact assessments when applicable to trace analysis and work with cross functional team members (design owners, E&L SMEs, materials, preclinical, etc.) to determine a comprehensive testing strategy through writing impact assessments, gap assessments, technical rationales and documents related to such change controls. Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization product development, design and safety. Interact across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to understand products and therapies, as well as business, technical, and regulatory requirements to meet project needs. Qualifications . -Demonstrated experience in applying trace analysis methods and tools as part of R&D -Knowledge of regulatory expectations related to trace analysis for drugs and devices. -Performing change control in a GMP environment. -Experience in working in global cross-functional teams for trace analysis projects -Independent problem solver who can use a methodical approach to develop solutions and make recommendations. Education and/or Experience. Bachelor s degree in scientific discipline (Analytical or Organic chemistry preferred) with a minimum 14 years of experience, or MS with a minimum 7 years of experience or PhD with a minimum 3 years of relevant experience. Recruitment Fraud Notice

Professors/ Assitant Professors(Medical College) Name:Professors/ Assitant Professors(Medical College)Role:Professors/ Assitant ProfessorsIndustry:Medical CollegeLocation:Udaipur (Rajasthan)Job Type:Full Time/ Part timeskills:Professors, MBBS, MS, MD Experience:2- 8yearsSalary:Best in the industryEducation:MBBS, MS, MD (Any specialization) Description: We are urgently hiring full time professors and assistant professors for Reputed Medical college.MBBS and PG in any stream can apply. ANATOMY, PHYSIOLOGY, BIOCHEMISTRY, PHARMACOLOGY, PATHOLOGY, MICROBIOLOGY. FORENSIC MEDICINE, COMMUNITY MEDICIN, GENERAL MEDICINE, PEDIATRICS, GENERAL SURGERY, OTHRO, OBSTERRICS, RADIO, PSYCHIATRY.Teaching and Education:Develop and deliver lectures, seminars, and laboratory sessions for medical students, residents, and fellows.Design curriculum, educational materials, and assessments to enhance the learning experience of students.Mentor and supervise medical students, residents, and fellows in clinical settings. Research:Conduct independent or collaborative research in your area of expertise. Publish research findings in peer-reviewed journals and present at conferences. Secure funding through grants and other sources to support research endeavors.Clinical Practice:Provide clinical care to patients within your specialty area. Stay updated with advancements in medical practices and technologies. Collaborate with other healthcare professionals to ensure comprehensive patient care.Administrative Duties:Serve on departmental committees and participate in decision-making processes. Contribute to the development and implementation of departmental policies and procedures. Participate in academic and professional organizations related to your field.Professional Development:Pursue continuous learning and professional development opportunities. Stay informed about changes and developments in the field of medicine. Engage in scholarly activities to enhance personal and professional growth.

Learning the operations of Analytical Instruments under the guidance of mentor. Learning the new Analytical Techniques used in Analytical Research Department. Coordination with Synthesis and other cross-functional departments. To ensure Good Laboratory & safety practices in the lab. Participate in ARD SOP trainings and other departmental trainings (Quality Assurance & EHS, HRD etc.) as and when required. Basic knowledge of instrumental technique with its application. analytical chemistry (HPLC/LCMS/NMR or purification) Person Profile Qualification: - M. Sc (Analytical Chemistry) Experience: - 0 years Any kind of internship or course work done at some Industry or reputed institute Jubilant is an equal opportunity employer. . ",

JOB DESCRIPTION Designation: Senior Executive- Electrical Job Location: Hyderabad Department: Engineering and Projects. About Syngene Incorporated in 1993, Syngene International has grown to become a major player in the contract research and manufacturing services domain. Syngene supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with Clinical development services. Syngene specializes in research and manufacturing of small molecules and large molecules for organizations around the world. The Companys facilities are audited and certified by health authorities from India, the USA, EU, United Kingdom and Russia, amongst others, for GMP related activities. Job Purpose: Involving in Facility, utilities, equipment Electrical Installation and qualifications in Manufacturing and development facilities for Syngene s Hyderabad operations. Key responsibilities: Planning, Monitoring and controlling of Day-to- Day project activates in Projects and engg. . Planning day-to day activities in accordance with the schedule. Follow up with field coordinators and vendors and ensure the tasks are completed as planned. Coordination with Consultants for GFCs . Involving in review and execution of utility and facility DQ, FAT, SAT and IQ OQ. Follow up with project related vendors and monitoring work relating to HVAC, GDS ,clean rooms, Electrical, IT, paneling, Utilities etc. Understanding, reviewing changes to the drawing related to Electrical works -Electrical , HVAC, Clean utilities, Plant Utilities, Layouts etc. Execution of facility and equipment commissioning and qualification of Syngene Compliance. Job analysis Preparation/Review, issuing field clearance as required. Ensuring Housekeeping at project site. Collaborating with Engineering cross functional for carry out field duties. Involving in URS creation and vendor technical evaluation for utility and facility in collaboration with engineering cross functionals. Ensuring Training compliance. Ensuring facility and equipment commissioning and qualification of Syngene Compliance in collaboration with the Quality department. Adhering to the company s established processes and rules and ensuring that the team does as well. Compliance with SOPs, cGMP and EHSS standards. Updating on day to day activates and subsequent plan with reporting manager. Educational Qualification: BE/BTech in Mechanical/Electrical Engineering . Diploma in electrical engineering Technical/Functional Skills. Good knowledge on Pharma/Biotech industry environment. Knowledge in GMP sterile facility quality system (DI, Deviation and change management). Knowledge in guidelines like ASME- BPE, EU GMP, ISO 14644, ALCOA principle. Bioprocess/Sterile operations will be plus. AutoCAD skills will be plus. Possess the knowledge and exposure to EHSS practices. Experience.: Overall 7-10 year of industry experience out of which 5 years of relevant manufacturing facility construction and management experience required. Good knowledge in CRO Industry . Good knowledge in cleanroom and Biosafety levels. Bio process/Sterile industrial experience is preferable. Behavioral Skills. Good in communication (written/oral) in English. Collaborative team player Growth mindset, positive approach. Quick learner. Equal Opportunity Employer: Syngene will not discriminate against any employee or job candidate based on age, color, physical ability, ethnic origin, nationality, religion, gender, family status, marital status, pre-natal status, gender reassignment, or sexual orientation, either directly or indirectly. We shall make appropriate accommodations for eligible workers or job candidates with disabilities wherever possible.

In-depth scientific expertise in Genotoxicology, with significant experience in designing, executing, and interpreting genetic toxicology studies in both regulatory (FDA, EMA, ICH, and OECD guidelines) and non-regulatory environments. Responsible for the execution, planning, performance, reporting/archiving, and management of studies such as the Bacterial Reverse Mutation Test (Ames Test), Bone Marrow Micronucleus Test, Chromosome Aberration Test, and In Vitro Micronucleus Test etc. Preparation of study plans, protocols, amendments to study plans, study reports, creation, and review of SOPs. Lead and manage a team of genetic toxicologists, providing mentorship and guidance to achieve departmental and organizational objectives. Oversee study directors across multiple studies and ensure consistent performance. Train and onboard new staff, ensuring they meet expected proficiency levels for quality work in compliance with GLP standards. Prepare monthly forecasts and reports, and plan for the effective use of resources. Focus on maintaining strong client communication, ensuring timely delivery of services, and fostering repeat business. Oversee laboratory maintenance, equipment validation and calibration, and procurement of reagent supplies. Participate in GLP/NABL activities, inspections, and ensure adherence to regulatory compliance guidelines; address Quality Assurance checklists and GLP compliance. Collaborate with HOS/HOD in budgeting, costing, planning, and conducting studies, as well as in the development of new platforms and operational activities. Support to business development and marketing efforts, generate new business leads alongside the BD team. Standardize and implement new in vitro test procedures. Qualifications / Skills Required: Masters in Microbiology (M.V.Sc / M.Sc) with at least 20-22+ years of relevant industry experience or PhD in Microbiology with at least 15+ years of relevant industry experience Understanding of the agrochemical and pharmaceutical R&D process Strong problem-solving skills and the ability to develop innovative solutions. Experience in managing internal and external collaborations. Willingness to adapt to rapidly changing scientific and regulatory environments. Effective team collaboration skills to achieve project goals, objectives, and deadlines. Behavioral Competencies: Strong oral and written communication skills. Ability to adapt and work efficiently in a dynamic environment. Excellent time management skills to effectively handle multiple projects. Highly motivated, takes responsibility for personal improvement, learning from experience and new situations. Strong training, presentation, analytical, and computer skills Thinks of and/or encourages new ideas and keen to experiment and see ideas implemented.

JOB DESCRIPTION Designation: Senior Manager - Reliability Engineer Job Location: Bangalore Department: Engineering and Maintenance About Syngene: Incorporated in 1993, Syngene International has grown to become a major player in the contract research and manufacturing services domain. Syngene supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with Clinical development services. Syngene specializes in research and manufacturing of small molecules and large molecules for organizations around the world. The Companys facilities are audited and certified by health authorities from India, the USA, EU, United Kingdom and Russia, amongst others, for GMP related activities. Mandatory expectation for all roles as per Syngene safety guidelines: Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time. Job Purpose: The Reliability Manager is responsible for developing and implementing strategies to ensure the reliability, availability, and performance of equipment, systems, and processes. This role focuses on improving asset performance, minimizing downtime, and optimizing maintenance practices through the application of reliability engineering principles, data analysis, and team leadership. Key responsibilities: 1. Strategic Reliability Management: Develop and implement reliability strategies, policies, and programs to improve asset performance and reduce failures. Establish and monitor key performance indicators (KPIs) for equipment reliability, downtime, and maintenance efficiency. Lead the development of a Reliability-Centered Maintenance (RCM) program. Drive the adoption of predictive maintenance techniques and technologies. 2. Asset Management and Maintenance Optimization: Perform asset criticality assessments to prioritize reliability efforts. Oversee the creation and optimization of preventive maintenance schedules. Ensure the effective use of tools like Failure Modes and Effects Analysis (FMEA) to identify and mitigate potential risks. Analyze Mean Time Between Failures (MTBF) and Mean Time To Repair (MTTR) to identify improvement areas. 3. Leadership and Collaboration: Lead and mentor a team of reliability engineers and maintenance professionals. Collaborate with operations, engineering, and maintenance teams to address recurring issues and improve reliability practices. Promote a culture of reliability excellence and continuous improvement within the organization. 4. Data Analysis and Reporting: Strong knowledge of reliability tools, techniques, and software (e.g., RCM, FMEA, CMMS, SAP). Analyse equipment performance data to identify trends and root causes of failures. Use advanced diagnostic tools and techniques (e.g., vibration analysis, thermography, oil analysis). Present reliability performance reports and recommendations to senior management. 5. Project Management: Manage reliability improvement projects, including planning, execution, and evaluation. Ensure projects are delivered on time, within scope, and aligned with organizational objectives. 6. Compliance and Standards: Ensure compliance with industry standards, regulations, and best practices related to equipment reliability and safety. Implement and maintain procedures for equipment reliability documentation and audits. Educational Qualification: BE/BTech in Mechanical Engineering . Experience: 15+ years of experience within Pharmaceutical, Petrochemical or Automobile industries. Reliability certification is a plus. Technical Skills: Proficiency in predictive maintenance tools and technologies. Excellent problem-solving and analytical skills. Strong project management and leadership abilities. Effective communication and interpersonal skills for cross-functional collaboration Key Performance Indicators (KPIs): Reduction in equipment downtime and failure rates. Improvements in OEE (Overall Equipment Effectiveness). Reduction in maintenance costs and increase in asset lifespan. Achievement of reliability goals aligned with organizational objectives. Equal Opportunity Employer: Syngene will not discriminate against any employee or job candidate based on age, color, physical ability, ethnic origin, nationality, religion, gender, family status, marital status, pre-natal status, gender reassignment, or sexual orientation, either directly or indirectly. We shall make appropriate accommodations for eligible workers or job candidates with disabilities wherever possible.

Experience (years) 20-22+ years relevant experience or PhD in Microbiology with at least 15+ years of relevant industry experience. Job description: In-depth scientific expertise in Genotoxicology, with significant experience in designing, executing, and interpreting genetic toxicology studies in both regulatory (FDA, EMA, ICH, and OECD guidelines) and non-regulatory environments. Responsible for the execution, planning, performance, reporting/archiving, and management of studies such as the Bacterial Reverse Mutation Test (Ames Test), Bone Marrow Micronucleus Test, Chromosome Aberration Test, and In Vitro Micronucleus Test etc. Preparation of study plans, protocols, amendments to study plans, study reports, creation, and review of SOPs. Lead and manage a team of genetic toxicologists, providing mentorship and guidance to achieve departmental and organizational objectives. Oversee study directors across multiple studies and ensure consistent performance. Train and onboard new staff, ensuring they meet expected proficiency levels for quality work in compliance with GLP standards. Prepare monthly forecasts and reports, and plan for the effective use of resources. Focus on maintaining strong client communication, ensuring timely delivery of services, and fostering repeat business. Oversee laboratory maintenance, equipment validation and calibration, and procurement of reagent supplies. Participate in GLP/NABL activities, inspections, and ensure adherence to regulatory compliance guidelines; address Quality Assurance checklists and GLP compliance. Collaborate with HOS/HOD in budgeting, costing, planning, and conducting studies, as well as in the development of new platforms and operational activities. Support to business development and marketing efforts, generate new business leads alongside the BD team. Standardize and implement new in vitro test procedures. Qualifications / Skills Required: Masters in Microbiology (M.V.Sc / M.Sc) with at least 20-22+ years of relevant industry experience or PhD in Microbiology with at least 15+ years of relevant industry experience Understanding of the agrochemical and pharmaceutical R&D process Strong problem-solving skills and the ability to develop innovative solutions. Experience in managing internal and external collaborations. Willingness to adapt to rapidly changing scientific and regulatory environments. Effective team collaboration skills to achieve project goals, objectives, and deadlines. Behavioral Competencies: Strong oral and written communication skills. Ability to adapt and work efficiently in a dynamic environment. Excellent time management skills to effectively handle multiple projects. Highly motivated, takes responsibility for personal improvement, learning from experience and new situations. Strong training, presentation, analytical, and computer skills Thinks of and/or encourages new ideas and keen to experiment and see ideas implemented.

- Assist in Dossier preparation and review various reports. - Coordinate with various institutes and Overseas experts on Toxicology, Efate and physiochemical part of dossiers - liaison, negotiate with labs and timely completion of studies -Chemicals Required Candidate profile Graduate or Post Graduate in Chemistry, Agriculture or Bioscience. Excellent in oral and written communication. Ability to manage complex issues and prioritize workload.

PDE / OEL calculation and report preparation OTC / Self-care formulas safety assessment Raw material safety assessment Extractable and Leachable safety assessment Impurity qualification INCI-Tox.Profile preparation for OTC / Self-care ingredients Authoring Non-Clinical Overview: Module 2.4 Toxicology literature review and report preparation

The Purpose of the Specialist role is having expertise in Extractables and Leachables assessment, and work in close collaboration with multiple functions such as MS&T, Supplier management, Regulatory, Toxicology, Procurement, Quality and Production. The individual plays a key role in support of Extractable and Leachable activities with a strong focus on data collection, Risk rating, assessments and evaluation. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: Understanding of Extractable and Leachable (E&L) risk assessment for materials based on supplier information and the ability to determine the risk level and update the Risk assessment. Building a comprehensive material library backed by corresponding E&L test data. Managing the coordination for Extractables studies or product-specific leachable studies. Preparation of E&L Risk assessment, E&L testing Protocol and Report. Compile E&L data and provide the information to Toxicologist for assessment. Proficient in risk evaluation, decision matrix, Gap Analysis, and outcome understanding manufacturing materials. Comprehensive knowledge of the chemical and physical properties (leaching tendency) of MOC materials. Skilled in defining the Original risk level, Mitigation factor, and Final risk level as part of the Risk Assessment process. Expertise in Extractable studies, their methodologies, analytical strategies, and design Expertise in setting the AET (Analytical Evaluation Threshold) and SCT (Safety concern threshold) for extractables and leachables detected during testing. Detailed understanding of E&L guidelines (SOPs, Pharmacopoeia and ICH standards, USP 665 & USP 1665 ) Proficient in identifying and assessing the Worst-case material representative approach. Collect the material list and data information from development centres and manufacturing sites. Active participation in E&L taskforce and network meetings. Also responsible for coordinating with the development, Supply management, QC, and Production department. What you ll bring to the role: Essential Requirements: Preparation of process and cleaning validation documentation (Protocols, reports) as well as change evaluations for new product launches and Life cycle management activities. Ensure project tracking documentation/tools are updated according to plan Collaborate closely with the development organization (or sending site) for technical transfers and new product launches to ensure knowledge transfer, appropriate control strategies, risk analysis and control, and readiness for commercial process validation Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting Coordination of documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable Preparation, approval and life cycle management of Gxp documents Experience: Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience. Min 8 years of experience in MS&T or in the manufacturing of pharmaceutical Drug substance and Product for Small and Large molecules. Should be familiar with regulatory guidance on ICH Q3,Validation, Product filing and Post approval changes. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). Expertise in reviewing and writing technical reports Good communication, Presentation and Interpersonal skills. Proficiency in English (oral and written) is required.

Key Responsibilities Should be well versed in method development, purification and characterization of NCE molecule. Must have a sound knowledge of Mass Spectrometry, Chromatography, HPLC, UPLC, prep HPLC, SFC and NMR is essential. SOP preparation, Problem solving, clients handling and to be able to maintain the quality in all related key areas. Maintain laboratory as safe working place. Should be able to handle a all analytical function of 2 units. Person Profile Qualification: - M. Sc (Analytical Chemistry) / Ph.D Experience: - 12 - 18 years of relevant experience. Should be able to handle a team of 35 - 40 members.

MilliporeSigma is looking for Senior Analyst - Regulatory Toxicology to join our dynamic team and embark on a rewarding career journey. The Senior Analyst plays a crucial role in driving data-driven decision-making processes within the organization. This position involves analyzing complex data sets, generating actionable insights, and providing strategic recommendations to support key business initiatives. Key Responsibilities : Data Analysis : Conduct in-depth analysis of large and complex datasets to extract meaningful insights. Utilize statistical and data visualization tools to present findings in a clear and concise manner. Strategic Planning : Collaborate with cross-functional teams to understand business objectives and provide analytical support for strategic initiatives. Develop and maintain models to support forecasting, budgeting, and other planning processes. Reporting and Dashboards : Design and create comprehensive reports and dashboards to track key performance indicators (KPIs) and metrics. Automate reporting processes to improve efficiency and accuracy. Trend Analysis : Identify trends and patterns in data to help anticipate opportunities and challenges. Provide insights on market trends, competitor analysis, and industry benchmarks. Decision Support : Assist senior management in making informed decisions by providing data-driven recommendations. Evaluate the impact of proposed strategies on business outcomes. Process Improvement : Identify areas for process improvement and efficiency gains based on data analysis. Collaborate with teams to implement changes and measure the impact.

Perform (eco)toxicological safety assessments of substances and products. Assessment of toxicological and ecotoxicological studies for hazard evaluation of substances: o Summarizing study data o Drawing scientifically sound conclusions based on regulation. o Data gap filling by using read across approach. To understand and be able to provide interpretation of regulatory guidance and emerging practice in the use of epidemiology, exposure scenarios and evaluate potential outcomes. Provide advice to internal stakeholders on human safety and toxicology across all phases of the research and development process, as well as providing expertise to support the development and registration of products. Experience of writing regulatory reports, prepare and participate in scientific consultations with regulatory authorities and industry. Prepare and participate in scientific consultations with regulatory authorities and industry. Defend key ingredients to regulatory authorities and public interest groups. Stay up-to-date with ongoing R&D efforts and projects in order to develop strategies for implementation of successful regulatory programs. Support compliance with GLOBAL REACH registration projects which includes registration, enforcement, training, internal audits, classification according to CLP. Support SDS Authoring compliance (GHS standards,EU/CLP, HCS/HazCom 2012) labels and other hazard communication information using a global product safety management system. Create and maintain Product Stewardship records relating to company products, intermediates and raw materials. Responsible for the continuing integration of Product Stewardship into business and R&D processes. Respond to internal and external product inquiries. Special projects and other duties as assigned by management. Stay up-to-date with new or changing international chemical control legislation through tracking and monitoring of the external regulatory environment,seeking out and reviewing regulatory information from external databases, industry/ regulatory authority communications, attendance of conferences and relevant national and regional trade associations and expert committee/panel meetings. Align this effort with that of other regulatory specialists in close collaboration with other key functions. Identify and communicate business opportunities and threats arising from current and future legislation and industry regulatory trends in line with business or company-wide objectives Maintain an understanding of the impact of new or changing legislation and manage and coordinate the strategically alignment with business managers regarding influencing regulatory developments or product defense through industry associations or expert groups. Skills and academic qualifications Educational Qualifications Functional Skills Functional Skills Required - Strategic Thinking, Judgment, Competitiveness Ethical Behavior Innovation, Analytical Ability Planning & Organization Flexibility, Ability to Deal with Change Interpersonal Sensitivity / Relationship Management Performance Standards, Tolerance of Str Relevant and total experience Total Number of experience required - 8+ years in ensuring compliance to current international chemical control or other relevant legislation, while developing and implementing a regulatory compliance program for the upcoming regulations. Relevant experience required in - This website use cookies We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We also share information about your use of our site with our social media, advertising and analytics partners who may combine it with other information that you ve provided to them or that they ve collected from your use of their services

Responsibilities : - Conduct comprehensive toxicology risk assessments across diverse scenarios, ensuring robust safety evaluations. Conduct & review of toxicology risk assessments for excipients, impurities, solvents, extractables and leachables, ensuring adherence to regulatory standards. Execute Environmental Risk Assessments (ERA) in compliance with the latest EMA guidelines. Prepare, maintain, and update toxicology summaries for globally marketed products in alignment with company policies. Develop and compile PDE and OEL monographs to support safety evaluations. Prepare clinical and non-clinical dossier modules (Modules 2.4, 2.5, 2.6, 2.7, 4, and 5) for regulatory submissions. Manage preclinical studies and associated documentation to ensure compliance and accuracy. Perform QSAR genotoxicity assessments in accordance with ICH M7 guidelines. Utilize advanced in-silico predictions (DEREK, SARAH, NEXUS, TOXTREE, OECD Toolbox) for data analysis and risk assessment. Provide expert guidance in addressing client and regulatory inquiries effectively. Background Required - Qualified Toxicologist Signing non-clinical/ toxicological reports/ modules/ expert reports Drafting of Environmental risk assessment reports Due diligence of pre-clinical data and drafting strategy for non-clinical studies for complex generics, NCEs, Biologics etc Drafting and review of non-clinical CTD modules Drafting of PDE reports Toxicological risk assessment of impurities/ leachables/ extractables Required education: Qualified and experienced Toxicologist Required experience : At least 2 years of experience in above mentioned activities.