Regulatory Specialist
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Location:
Seoul, Korea Business Unit / Group Function: Material Protection Products If the chemistry is right, we can make a difference at LANXESS: speed up sports, make beverages last longer, add more color to leisure time and much more. As a leading specialty chemicals group, we develop and produce chemical intermediates, additives, specialty chemicals and high-tech plastics. With more than 13,000 employees. Be part of it Job Purpose Obtaining registrations of MPP products and active substances under all Korean legislations. Classification and Labeling of such products. Quality manager for veterinary products. Ensure business compliance with South Korea regulations. The pharmacist diploma is a prerequisite for Biosecurity products in Korea. Job Highlights
• Korean BPR: Approval of active substances and biocidal products (compilation of data to ensure submission, close cooperation with consultant and monitor legislation updates)
• National legislation: Assessment and dossier preparation to support registrations and regulatory activities for Veterinary Products, Medical Device & Pharmaceutical Act Registrations -etc.
• Pharmacist & Quality manager for Veterinary products. Manage the import, storage, and distribution of veterinary medicines. Maintain quality records and import documentation and pepare and assist inspection from authorities. In-site audits to check compliance with regulations at downstream users and distributors
• Ensure compliance with Korea CCA (Chemical Control Acts), Korea REACH with support of PTSE Monitor the evolution of regulations, and industry initiatives
• Documentation & Regulatory customer requests: Ensure the documentation is update at the relevant repository, answer request in due time. Use and maintenance of QM systems for scientific data and registrations Work Experience
• Pharmacist License
• Regulatory experience; i.e. K-BPR, K-REACH, K-MDR
• Communication internal & external interface (Fluent in English)
• Computer skills
• Classification and Labelling of Chemical Products Benefits
What We Offer
You Compensation:
We offer
competitive compensation packages, inclusive of a global bonus program and an individual performance bonus program. Comprehensive
Benefits:
We provide a variety of benefits to support your financial security, health and wellbeing including retirement plans, health programs, life insurance and medical care. Work-Life & Flexibility: We support you in maintaining a balance between
working hours
and personal life. With our global “Xwork” program,
we offer
flexible working arrangements in all countries in which we operate. Training & Development: We are committed to your professional and personal development and encourage you in the ongoing pursuit of education, training and knowledge through both formal and informal learning . Diversity: For us, talent matters, we welcome everyone who commits to our values. We strongly believe that including diverse perspectives makes us more innovative and enhances our competitiveness. Therefore, we embrace the uniqueness of every single individual and are truly committed to supporting our people in developing their individual potential.
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