职位描述
Role Overview:
1. Responsible for setting up the product registration plan per marketing’s registration request
2. Responsible for registration of Recon product according to the timeframe of registration plan
3. Responsible for following up type testing, preparing submission documents, communicating with CFDA authority during technical evaluation period, conducting in compliance with local regulatory agency requirements and relevant SOP.
4. Responsible for good documentation management.
5. Responsible for providing regulatory support to relevant department
6. Responsible for establishment of good working relationship with regulatory agencies and GBU supporting team
Please include specific internal and external relationships, product focus (if any), regulatory requirements, etc.
Responsibilities: (Please specify % amount against each responsibility)
This is the key position of Recon product registration in China. Anna is the RABP to support Recon business unit and lead a registration team with two team members. Under that postion, the staff needs to:
1. Set up the registration plan for Recon products according to marketing launch plan or expiration date of original certificate, keep good communication with supervisor and co-worker, provide monthly update for the projects (15%);
2. Follow up testing and technical review for the registration ( 30%)
3. Cooperate with local marketing and sourcing company, push the whole registration process going forward as planed following the SOP requirement. ( 20 %)
4. Set up good relationship with authority from testing centre and technical evaluation centre. (10 %)
5. Lead Recon registration team to proceed all initial and renewal registration in China according to the plan to support Recon business growth in China, review the registration process with team member and coach junior team member as well(10%)
6. Keep good documentation management for the registered products. ( 5%)
7. Provide the regulatory support to other departments in daily work ( 5%)
8. Lead RA project and make sure it’s completed as planning ( 5%)
Location: Beijing commercial
Education: Bachelor and above
Licenses/ Certifications:
Experience: 5 years+ registration experience
Competences:
Physical Demands:
Medical or biological background, come from science department in a college is preferred.
English communication ability, read and write fluently, simple spoken English at least
Team work spirits
