薬事リーダー/ Regulatory Affairs Lead

An international chemical manufacturer is looking for a Regulatory Affairs Lead. The selected applicant will provide regulatory support and guidance to ensure product compliance with Japan regulations. This is a hybrid role.

Responsibilities:

• Provide overall regulatory support, including development of regulatory strategies and timelines, preparation, submission, and maintenance of chemical management regulatory filings to ensure compliance with Japan regulations
• Assess current products to ensure compliance with applicable Japan regulatory requirements
• Conduct chemical regulatory evaluations and manage submissions to the Ministry of Health, Labor and Welfare (MHLW), Ministry of Environment (MOE), Ministry of Economy, Trade and Industry (METI), and under the Industrial Safety and Health Law (ISHL)
• Conduct Poisonous and Deleterious Substances (P&DS) permit applications and renewals
• Provide internal and external customer support related to registration activities, collaborating cross-functionally to develop and implement robust regulatory strategies
• Participate in cross-functional product development and commercialisation teams as required, providing guidance on global regulatory requirements and strategies
• Coordinate and review product testing conducted by internal teams or external consultants to ensure regulatory compliance and complete required regulatory submissions
• Execute hazard communication activities for all products in Japan, including preparation and maintenance of Safety Data Sheets (SDS) and labels using the SAP EHS system, as well as implementation of PRTR and ISHL regulatory requirements
• Develop and maintain strong internal partnerships with Product Development, Sales, HS&E, Supply Chain, and other relevant stakeholders to support compliance activities

Requirements:

• Bachelor’s degree or above in Chemistry, Environmental Science or other related scientific discipline
• More than 5 years of relevant experience in preparing and executing regulatory submissions on a national and international level
• In-depth knowledge of Japanese chemicals regulations (CSCL, ISHL, etc.)
• Ability to understand and interpret technical and regulatory documents
  

Preferred Requirements:

• Regulatory Affairs Certification (RAC) or equivalent
• Knowledge of other regional programs (such as China MEE Order No. 12, Taiwan REACH, Korea REACH, US TSCA, etc.)
• Proficient in written and verbal Japanese and English

About the Company:

A global specialty chemicals company providing innovative solutions and products to a wide range of industries worldwide.

Keywords:

化学品, 製造業者, コンプライアンス, 外資系

Job Ref: OJCNEA