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About this Regulatory Affairs and Product Safety Specialist role at Thermo Fisher Scientific

Thermo Fisher Scientific · Onsite · Shanghai, China

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary

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.

Key Responsibilities

·   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.

Minimum Requirements

Education

Bachelor's degree or above in Chemistry, Chemical Engineering, Environmental Science or a related scientific discipline.

Experience

2+ years of experience in chemical regulatory compliance, product stewardship, EHS or related regulatory functions.

Knowledge, Skills & Competencies

·   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.

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About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosyste

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