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Regulatory operation manager

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

Job Requisition ID:  187768
Location:  Tokyo
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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