Regulatory operation manager/ Biopharma(Tokyo)

Posted 06 Feb 2019

Tokyo, Tokyo-To - Japan

Req Id 187768

Details

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Job Description:

- Ensures preparation, Quality check and dispatch of submissions for assigned product portfolio in a timely manner
- Manages the publishing, production and archiving of dossiers and regulatory documents across the product lifecycle for assigned projects
- Drives and utilizes the usage of new technologies in the area of dossier and submission management
- Works with substantial discretion and uses best practice and knowledge of internal and external business issues to improve products or services
- Uses specialist knowledge, analytical skills, judgement and broad conceptual and practical experience to solve complex problems and to contribute to process improvements
- Understands how the different teams jointly achieve the objectives of the area and uses knowledge of the organization, processes, customers and key business driver to increase effectiveness
- Ensures relevant Regulatory knowledge to be shared within local and global organization
- Supports implementation and usage of Regulatory relevant tools/applications for Japan

 

Candidate profile:

Education

  • Requires a graduate degree (or equivalent) that provides knowledge of theories, principles and concepts within a descipline
  • Degree in lifesciences or related discipline or relevant regulatory experience

    Work Experience

  • Requires substantial professional experience (approximately 4-6 years)
  • Thorough understanding of the Regulatory Informatics and Submission Management area, including process and technology solutions
  • Project Management experience
  • Organizational and presentation skills
  • Knowledge of regulation/guideline development processes in health authorities or international organization
  • Experience with information science for scientific/regulatory needs
  • Experience with regulatory maintenance activities in a local affiliate or head office
  • Experience in the maintenance of information databases
  • Demonstrated communication/training skills

    Job specific Competencies & Skills

  • Fluent command of spoken and written English
  • Excellent knowledge of German depending on location
  • Outstanding ability to work in teams and positively influence team spirit
  • Excellent result orientation and willingness to take ownership
  • Strong customer orientation
  • Strong communication skills
  • Strategic thinking
  • Ability to work effectively as part of a global organization
  • Personal adaptability and innicaitaives

Recruiting contact: Fang Liu


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