Regulatory Affairs and Product Safety Specialist
Thermo Fisher Scientific
Regulatory Affairs and Product Safety Specialist
Thermo Fisher Scientific
Makes lab instruments, reagents and supplies
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
The Specialist, Regulatory Affairs and Product Safety is the primary resource supporting chemical regulatory compliance for the Laboratory Chemicals Division (LCD) in China.
The position is responsible for the day-to-day execution of established chemical compliance processes, including product screening, regulatory documentation preparation, controlled chemical filings, SDS and label coordination, regulatory data maintenance, warehouse and customs support, and case follow-up.
· Perform regulatory screening and compliance checks for new and existing chemical products in accordance with established China regulatory requirements and internal procedures.
· Support new chemical substance registration, hazardous chemical registration, controlled chemical filings, license maintenance and other required regulatory submissions by preparing documentation, collecting data and tracking completion.
· Coordinate the preparation, review and update of Chinese SDS, product labels and other regulatory documentation to support product importation, warehouse release and commercialization.
· Maintain chemical regulatory and product compliance data in applicable business systems, including Product Master Data, regulatory databases and WMS-related records.
· Support implementation of regulatory updates and internal compliance process changes under the guidance.
· Participate in compliance projects, data cleanup, process improvement and digitalization initiatives as assigned.
Bachelor's degree or above in Chemistry, Chemical Engineering, Environmental Science or a related scientific discipline.
2+ years of experience in chemical regulatory compliance, product stewardship, EHS or related regulatory functions.
· Working knowledge of China chemical regulatory requirements and product compliance processes.
· Ability to follow established regulatory procedures and accurately execute recurring compliance activities.
· Good analytical, organizational and problem-solving skills.
· Strong attention to details.
· Good stakeholder coordination and cross-functional collaboration skills.
· Effective written and verbal communication skills in both English and Chinese.
· Ability to manage multiple operational priorities and follow up on open cases in a matrix organization.
Makes lab instruments, reagents and supplies
Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.
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