薬事シニアマネージャー/ Regulatory Affairs Senior Manager

A pioneering pharmaceutical company is looking for a Regulatory Affairs Senior Manager. The selected candidate will work with global teams to define regulatory strategies and manage the submission of regulatory documents.

Responsibilities:

• Define development and regulatory strategy with local and global teams
• Lead or support regulatory and CRO activities for specific products
• Provide strategic regulatory advice as a member of global regulatory teams
• Coordinate and respond to regulatory authorities' inquiries within strict deadlines
• Maintain and organize regulatory files per internal standards
• Review and recommend changes to regulatory documentation and processes

Requirements:

• Bachelor’s degree or above (advanced science or healthcare degree is a plus)
• More than 5 years of experience in regulatory affairs and clinical development role
• Experience in interpretation of guidelines
• Prior experience with regulatory filings (electronic submissions)
• Knowledge of regulations
• Excellent technical system skills
• Native level Japanese; business level English

About the Company:

A pioneering pharmaceutical company focused on advancing innovative therapeutic solutions. Committed to scientific excellence, it aims to improve patient outcomes through cutting-edge research and development.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: H423NO