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Regulatory Affairs Manager

JT Laurel Consultancy Limited

  • Company Industries:Others

Job Information

  • Post Date:2018-02-27
  • Career Level:Middle
  • Location:Not Specified
  • Salary:Salary provided
  • Employment Type:Full Time, Permanent
  • Job Function:Others  

Job Description

Responsibility

  1. Efficiently communicate with regional and global team for all regulatory related matters
  2. Review and approve proposed product packaging, advertising and promotional materials after evaluating conformance to regulations
  3. Provide regulatory guidance about preparation, review and approval of labeling to ensure the company complies with local country’s requirements pertaining to labeling
  4. Provide support to tender applications/subimission, communicate with Department of Health and Hospital Authority as well as respond to their queries
  5. Liaise closely with our Production and Quality Control Department regarding documentation and product files
  6. Lead efforts to ensure regulatory files, logs and documentation are maintained as required to ensure data can be shared across the organization in efficient manner
  7. Undertake other ad hoc projects as assigned
  8. Provide regulation assessment for developing marketing strategy to support business growth
  9. Participate in the problem-solving process by monitoring issues and implementing strategies for resolution. Analyze and interpret information, impacting regulatory decisions
  10. Review various changes for compliance and complete assessments of regulatory impact
  11. Keep abreast of new regulations in the region 

 

Requirement

  1. Degree in Science/Nutrition is preferable
  2. Minimum 5-year regulatory experience with pharmaceutical or healthcare related
  3. Strong communication and interpersonal skills
  4. Experience in labeling management
  5. Detail oriented and able to work independently
  6. Good command of written and spoken English and Mandarin
  7. Experience in FSMP product will be a strong advantage
  8. Attentive to details, strong sense of responsibility
  9. Well-organized, self-motivated, positive working attitude and with good team spirit
  10. Pleasant personality with excellent presentation, interpersonal and analytical skills

 

 

 

Company Info

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