Primary Function:
The position performs the preparation and administrative portions for the different regulatory services and deliverables and support department relative contributes, e.g. the regulatory projects or Intelligence.
Key Responsibilities:
Project Execution
- Support and perform the preparation and administrative portion for different regulatory services, included but not limited to CTD authoring customization and integration, CTD document preparation and publishing, country paper and electronic submission, gap analysis customization and integration, consultation meeting arrangement, Regulatory project coordination supports and support the liaison with Authority according to the regulatory requirements, service scope and client's expectation.
- Provide administrative/coordination support and perform regulatory activities including the preparation for the initial submissions and the life cycle for the clinical study and product licenses.
- Check and collect the regulatory updates and support the regulatory intelligence update.
Commercial Support
- Support department to prepare the description for proposed Regulatory Service and/or the sales presentation
Support department to contributes information for the account planning process and integrated marketing programs
- 0-2 years RA related experiences or different subject matter, e.g. Regulatory operation, CMC or non-clinical discipline and/or eCTD publishing/submission tasks
- Understanding country regulatory infrastructure and global standard, e.g. ICH guideline
- Good communication, organization, attention to detail.
- Ability to work effectively with internal and external team.
Ability to communicate and write English clearly, concisely, and effectively.
Education Required
Bachelor's degree or above in life science, pharmacy, medical or industry related discipline (pharmacology, pharmaceutical analysis, biological science, cell and molecular biology, molecular engineering, chemical engineering or medical related)
language:fluent in both English and Chinese
