1. Maintain product licenses through timely renewal to high standard.
2. Provide guidance on license strategy to product development, make product registration plans for new developed products/significant changes, and perform the registration as per plan. (Including but not limited on registration budget, timing, regulatory level requirement, in-China type testing, NMPA registration)
3. Provides guidance and advice to function departments on regulatory affairs to ensure registration projects completed timely.
4. Keep a good communication with the regulatory authorities and testing center to ensure any regulatory application of BU to obtain an optimal results and timely feedback on the request from regulatory authorities.
5. Fulfill process & infrastructure for documentation, dossier preparation and information provided to regulatory authorities as request.
6. Actively communicate with NMPA reviewers for technical discussion and Panel Meeting.
7. Regulatory assessment of Change Control to ensure the compliance (e.g. RA survey and CN).
8. Ensure compliance and consistency of product labeling and IFU with local requirements. Assistant RA data management to complete the Chinese label and Chinese IFU data confirmation and maintanice, to establish/change/update accordingly when a product license is new issued/updated/extended.Manage all product associated document. Well filing and retain the documents and records. Well control key documents, eg. Chinese label and IFU, and timely communicate update/changes with quality/global team
9. Ensure assigned projects are approved on agreed timeline and closely communicate with site/Logistics to ensure smooth of supply.
10.Follow SOP requirements especially on documentation; Well-manage all data stated on product license and internal system. Make sure regulatory compliance.
11. Workng with sales and marketing dept. to fulfill product registration plan and achieviming expectation on proudct registration. (including HK/TW area registration coodination for some of BU)
12. Other issues related with product registration activity.
1.Support tendering documentation preparation as requirement. Draft the RA declaration letter for Varity request from internal and external if necessary. (Related RA only)
2. Support RA manager to analyze impact of regulatory environment change on BU business and propose actions which RA needs to takenitiatives and/or industry association joint forces.
3.Responsible for RA related SOP/WI maintenance and implementation
1.Draft the non-registration RA declaration letter for varity request from intenral and external if necessary
2.Escalate any issues or concerns within the functional line and/or relevant leadership for adjudication.
3.Provides regulatory support to other departments, including Tendering, R&D, Supply Chain, Marketing etc.