規制プロセスリード/ Regulatory Process Lead

A multinational pharmaceutical company is seeking a Regulatory Process Management Lead. The selected candidate will lead the submission planning and execution process for Japan, while ensuring regulatory systems and processes are optimised and compliant. This is a hybrid setup role.

Responsibilities:

• Serve as the Source Submission (Veeva) expert within Regulatory Affairs Japan and interface with teams
• Collaborate across submission teams and departments to develop effective workflows
• Act as the key contact for regulatory submission tools and digital systems
• Implement and update process documentation based on regulatory and business requirements
• Support process improvement initiatives and assist the Business Process Lead
• Liaise with system stakeholders, vendor partners, and application owners to improve regulatory tools
• Manage and maintain procedural documentation and process landscapes
• Represent Regulatory Affairs Japan as a technical point of contact

Requirements:

• Bachelor’s degree or above
• More than 10 years in the pharmaceutical or related industry
• More than 3 years of experience in Regulatory Operations or Labelling, and implementing new technologies
• Proficient in Excel, Business Objects, MS Office, VEEVA
• Knowledge of computer system validation requirements
• Ability to manage confidential information and adapt in multicultural settings
• Business level English

About the Company:

A global pharmaceutical organisation that delivers cutting-edge products and services to meet patient needs. With employees in several countries, this is an excellent company to work for.

Keywords:

規制プロセスマネジメント, 製薬業界, 申請計画, 電子システム, プロセス改善, デジタルツール, バリデーション, プロジェクトマネジメント, ステークホルダーマネジメント, 求人, 外資系

Job Ref: EZ7OXB