規制業務アソシエイト/ Regulatory Affairs Associate

A global pharmaceutical company is seeking a Regulatory Affairs Associate I (Project Manager). The successful candidate will coordinate regulatory submissions, documentation, and compliance activities for the Japan market.

Responsibilities:

• Coordinate DMF preparation and ensure timely submissions for Japan market
• Collaborate with regulatory associates and internal teams on product-related activities
• Manage responses to deficiency letters and coordinate corrective actions
• Support pre-launch activities and oversee regulatory aspects of assigned APIs
• Evaluate and process change requests to ensure regulatory compliance
• Maintain up-to-date DMFs in line with Japan’s regulatory requirements

Requirements:

• Bachelor’s degree or above (chemistry, biochemistry, biology, or biotechnology)
• Proficient in written and verbal English

About the Company:

A global pharmaceutical organisation, this company is one of the largest and most successful enterprises in the industry. With a long history and a presence in countries across the globe, this company continues to be an international leader in the pharmaceutical world.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: V0QDI5