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CMCレギュラトリーマネージャー/ CMC Regulatory Manager

Remote: 
Full Remote
Contract: 
Experience: 
Expert & Leadership (>10 years)
Work from: 

Robert Walters logo
Robert Walters Human Resources, Staffing & Recruiting Large https://www.robertwaltersgroup.com/
1001 - 5000 Employees
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Job description

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Your missions

An international regulatory services/CRO company is looking for a CMC Regulatory Representative – Manager. The selected candidate will develop and implement CMC regulatory strategies. This is a long-term haken and remote setup position.

Responsibilities

  • Develop and implement CMC regulatory strategies for pharmaceutical products
  • Lead the preparation and submission of CMC dossiers
  • Serve as the CMC Product Lead for assigned products
  • Aid in developing and executing global product and project regulatory strategies
  • Collaborate with clients and external partners to support change management
  • Manage execution of CMC documentation for post-approval changes
  • Assess and communicate potential regulatory risks and propose mitigation strategies
  • Deliver regulatory milestones and communicate potential regulatory issues

Requirements

  • Bachelor’s degree or above in life sciences, health sciences, or pharmaceutical sciences
  • 12-15 years of relevant CMC pre/post approval experience
  • Strong experience in CMC requirements
  • Proven experience in critically reviewing detailed scientific information
  • Effective leadership and interpersonal communication skills
  • Native level Japanese; proficient in English

About The Company

A leading company in regulatory services and clinical research, known for its innovative solutions and commitment to excellence. With a strong global presence, the company focuses on providing top-tier regulatory support to the pharmaceutical industry.

Keywords

CMC規制, 製薬, 申請書類, 規制戦略, 規制当局, 品質保証, 変更管理, チーム管理, 求人, 外資系

2055310/001

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
Check out the description to know which languages are mandatory.

Soft Skills

  • Leadership
  • Interpersonal Communications
  • Collaboration

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