About this role
Job Requirements
- 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 forVeterinary 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
Required Skills
- 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