HireDiversity

Shanghai, CN

RA Specialist-000006G4

Description
- Product registration related including new and renewal

o Handling registration process for S1/S2, including
- document requirement
- dossier prepare
- submit to SFDA
- follow up evaluation procedure
- sample ordering, type testing
- solve various problems in whole process
- file dossiers with consistent requirement

o Ensure to obtain the regulatory permits on time, in support of the organization's business requirements

o Having a good and consistent communication with local marketing and known well the business plan especially product launch plan

o Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration

o Paying attention to the market information such as the competitors' with the analysis
- To coordinate the post market surveillance project
- Supporting Chinese IFU /labeling, copy review for product related
- Being involving into team working such as department meeting logistic arrangement
- Maintain & Input database like: RA database, RTL…
- Providing monthly report & analysis including latest registration status & post market surveillance
- Develop Regulatory Strategy and Plan for Chartered R&D Initiatives from Sourcing Companies and Partner with the project team to ensure the approval at each review gate.
- Other responsibilities defined in written procedures.

Qualifications

- Medical or related education background and knowledge
- 1~2 years experience in Regulatory Affairs
- Good communication skill
- Good time management
- Well computer operating
- Better English and Chinese in writing and oral

Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Regulatory Affairs