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レギュラトリーリード バイオファーマ/ Regulatory Lead BioPharma

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A renowned pharmaceutical company is looking for a Japan Regulatory Lead in the BioPharma Therapy Area. The selected candidate will develop and execute regulatory strategies for assigned products.

Responsibilities:

  • Lead the planning and execution of Japan regulatory strategy for assigned products
  • Provide strategic regulatory expertise for market access as a member of Japan and global regulatory teams
  • Communicate global regulatory strategy and implications to Japan for governance decision-making
  • Prepare and implement regulatory operational plans for product lifecycle management
  • Ensure quality regulatory deliverables throughout the product’s lifecycle
  • Provide cross-therapeutic area operational and strategic regulatory support

Requirements:

  • Bachelor’s degree or above in Science or related field
  • Proven regulatory experience or relevant pharmaceutical industry experience
  • Experience in cross-functional project teams
  • Knowledge of drug development process
  • Possess a valid authorisation to work in Japan
  • Native level Japanese; business level English

About the Company:

This company is an innovative world leader in biopharmaceutical research with a strong international presence. It is focused on several areas to develop effective medicines for many major diseases.

Keywords:

薬事規制, 医薬品開発, 市場アクセス, プロジェクト管理, バイオ医薬品, 求人, 外資系

2108360/001

Contract Type: FULL_TIME

Specialism: Healthcare

Focus: Regulatory Affairs

Industry: Pharmaceuticals

Salary: ¥8,000,000 - ¥12,000,000 per annum

Workplace Type: On-site

Experience Level: Mid Management

Language: Japanese - Professional

Second Language: English - Professional

Location: Osaka

Job Reference: 2108360/001

Date posted: 03 October 2024

Consultant: Junji Okazaki

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