Johnson & Johnson Careers
Assistant Regulatory Affair Manager
Requisition ID: 1905726300W
Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
- Product registration related including new and renewal
- Handling registration process for S1/S2, including
- Document requirement
- Dossier prepare
- Submit to CFDA
- Follow up evaluation procedure
- Sample ordering, type testing
- SoIve various problems in whole process
- File dossiers with consistent requirement
- Ensure to obtain the regulatory permits on time, in support of the organization's business requirements
- Having a good and consistent communication with local marketing and know well the business plan especially product launch plan
- Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
- Paying attention to the market information such as the competitors ’ with the analysis
- To coordinate the post surveillance project
- Supporting Chinese IFU/labeling, copy review of product related
- Being involving into team working such as department meeting logistic arrangement
- Maintain& Input database such as: RA database, RTL etc.
- 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.
- Work closely with marketing team in providing effective operational support for entire product registration lifecycle.
- Being sensitive to capture the regulatory information to support company policy statement and contribute the constructive option for regulatory environment shaping.
- Provide regulatory assessment/expertise at the early stage of strategic, NBD and R&D Initiatives to company project team.
- Map the work model to standardize internal work flow for all types of registration work Marco and micro to lead the group on marketing analysis to adjust regulatory strategy in time.
- Help team members to build a collaborative, high performing team.
Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
- Medical or related education background and knowledge
- 3-5 years’ experience in Regulatory Affairs
Skill Sets and/or Training and/or Certification for the Special Position
Good communication skills
Good time management skills
Well computer operation skills
Better English and Chinese in writing and oral
Johnson & Johnson Medical Shanghai Ltd. (7055)