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
- Efficiently communicate with regional and global team for all regulatory related matters
- Review and approve proposed product packaging, advertising and promotional materials after evaluating conformance to regulations
- Provide regulatory guidance about preparation, review and approval of labeling to ensure the company complies with local country’s requirements pertaining to labeling
- Provide support to tender applications/subimission, communicate with Department of Health and Hospital Authority as well as respond to their queries
- Liaise closely with our Production and Quality Control Department regarding documentation and product files
- 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
- Undertake other ad hoc projects as assigned
- Provide regulation assessment for developing marketing strategy to support business growth
- Participate in the problem-solving process by monitoring issues and implementing strategies for resolution. Analyze and interpret information, impacting regulatory decisions
- Review various changes for compliance and complete assessments of regulatory impact
- Keep abreast of new regulations in the region
Requirement
- Degree in Science/Nutrition is preferable
- Minimum 5-year regulatory experience with pharmaceutical or healthcare related
- Strong communication and interpersonal skills
- Experience in labeling management
- Detail oriented and able to work independently
- Good command of written and spoken English and Mandarin
- Experience in FSMP product will be a strong advantage
- Attentive to details, strong sense of responsibility
- Well-organized, self-motivated, positive working attitude and with good team spirit
- Pleasant personality with excellent presentation, interpersonal and analytical skills
Company Info
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