レギュラトリーエキスパート/ Regulatory Expert

An international technology company in the life science sector is searching for a Regulatory Expert. The selected applicant will be responsible for ensuring the company’s products are compliant with Japanese regulations. This is a hybrid role.

Responsibilities:

• Review and understand PMDA Regulations as described in the “Green Book” and other PMDA notifications
• Assess the impact of the regulations on the products
• Ensure timely product updates to comply with the regulations
• Monitor PMDA communications, especially regarding Japan regulations
• Interact with customers via Industry Standard Practices forum and other channels to understand customer requirements
• Manage the ISP process along with the Product Owner
• Participate in Agile scrums along with the Product Owner

Requirements:

• Bachelor’s degree or above
• More than 10 years of experience working for a Japanese life sciences company in pharmacovigilance or other departments where Japanese pharmacovigilance regulatory knowledge was required
• Experience in developing use cases (description of product function)
• Deep understanding of the Japanese and global pharmacovigilance process
• Knowledge of Greenbook, and other PMDA notifications
• Ability to communicate Japanese regulations to non-Japanese engineers in English
• Native level Japanese; business level English

About the Company:

A global IT company in the life sciences sector. The company has a long history of specialising in building cutting-edge technology platforms that revolutionise healthcare around the world.

Keywords:

コンプライアンス, 薬事規制, ライフサイエンス, ファーマコビジランス, IT, ソフトウェア, 外資系

1932030/001