薬事スペシャリスト/ Regulatory Affairs Specialist

An international chemical company is searching for a Regulatory Affairs Specialist. The selected applicant will be responsible for handling product stewardship tasks and addressing local regulatory issues.

Responsibilities:

• Monitor national chemical legislation developments in Japan
• Ensure chemical management follows regulatory requirements
• Maintain product data for SDS, labelling, compositions, registration status, Sentinel, and documentation in EH&S based on GL 26 requirements
• Provide PS expertise and implement region-specific SAP- EH&S maintenance
• Respond timely to customers' requests concerning product safety issues under GBS TT
• Coordinate and support new substance registration projects under the PS team in Japan
• Ensure regulatory compliance including registrations of chemicals for the company’s products
• Create and submit annual reports to authorities based on regulation requirements

Requirements:

• 5-10 years of experience in PS regulatory affairs or product stewardship in a multinational company
• 5-10 years of PS experience in a regulatory environment in the chemical industry
• Prior chemistry background
• Understanding of the SAP EHS system
• Knowledge of Japan chemical control regulations
• Good communication and presentation skills
• Proficient in English

About the Company:

Headquartered in Europe, this global company manufactures and distributes specialty chemicals across a variety of industries. With several decades of history and tens of thousands of global workforces, this company is a true market leader.

Keywords:

薬事, 化学, メーカー, 規制, 外資系

2107660/001