レギュラトリー・アフェアズ・ディレクター/ Regulatory Affairs Director

A global healthcare company is searching for a Regulatory Affairs Director to join their organisation. The candidate fit for this position will be accountable for initiating regulatory strategies and management.

Responsibilities:

• Develop and update existing regulatory strategies
• Prepare quality regulatory documentation for submission and approval
• Identify necessary regulatory requirements related to project needs
• Manage negotiation activities with authorities to boost document approval
• Provide guidance regarding regulatory requirements to development teams
• Oversee license, registration, and listing processes
• Ensure compliance with local, regional, and global policies

Requirements:

• Bachelor’s degree or equivalent
• Master’s degree in a scientific discipline is preferred
• 8+ years of experience in regulatory, research and development, medical or a related field, preferably in the pharmaceutical sector
• Prior experience in liaising with government regulatory agencies (PMDA, MHLW)
• Proven work experience with government affairs, medical, and market access is beneficial
• Fluent in English

About the Company:

An industry leading healthcare firm that focuses on innovative pharmaceutical products. This company offers medical devices, diagnosis, and healthcare services.

Keywords:

経営, セールス, バイオ製薬, 製薬, 製薬業界, 医薬品, 生医学, ライフサイエンス, 生命科学, 医療, メディカル, ヘルスケア, 医療機器, 求人, 外資系

1682220/001