RAスペシャリスト/ RA Specialist

A global pharmaceutical manufacturing company is looking for an RA Specialist. The selected candidate will oversee regulatory submissions and compliance for active pharmaceutical ingredients in Japan.

Responsibilities:

• Coordinate product submission and renewal processes with PMDA and regulatory agents
• Ensure product files meet Japanese regulatory requirements
• Provide technical documentation and updates to clients
• Evaluate change control impacts on regulatory dossiers
• Conduct training and provide technical support in regulatory affairs
• Share regulatory updates and maintain compliance with HSE policies

Requirements:

• Bachelor’s degree or above in pharmaceutical sciences, chemistry, or natural sciences
• More than 5 years of experience in regulatory affairs (active pharmaceutical ingredients or drug product)
• Understanding on quality, cGMPs, ICH guidelines, and Japanese and international legislations relevant to pharmaceutical products
• Ability and willingness to travel
• Professional level written and verbal Japanese and English

About the Company:

This company specializes in developing and manufacturing active pharmaceutical ingredients (APIs), drug product intermediates, and particle engineering solutions. Operating globally, it supports clients from early-stage development to commercial supply, maintaining a strong commitment to quality and innovation.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系, 大阪 求人

Job Ref: CSK3RH