職位描述
Who we are:
At Roche, 90,000 people across 150 countries are pushing back the frontiers of healthcare. Working together. Our success is built on innovation, curiosity and diversity.
As the worldwide market leader in in-vitro diagnostics, Roche is committed to providing the latest cutting-edge diagnostic solutions to advance the health and wellness of people worldwide. Roche Diagnostics (Suzhou) Ltd. was established in April 2015, with approximate investment of 450 million CHF and went into operation in end of 2018.
The new manufacturing site with a R&D center in Suzhou, China, addresses the growing demand for diagnostic tests in China and the Asia Pacific region; ensuring people have access to high-quality reagents, while providing a long-term sustainable contribution to meet the healthcare needs of the region.
Who you are:
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.
Where a job title is not considered the final definition of who you are, but the starting point.
What we expect you could, as each colleague around you, aim high and think out of the box, embrace new changes and things with open mind. Confront challenges with passion and courage. Work with colleagues with integrity and keep up the good job.
Job Summary:
- Responsible for Support RDSL MRA team to ensure timely initial and renewal registration, respond to Authority inquiry or to resolve Authority issue in relation to RDSZ C4C products.
- Cooperate with global regulatory affairs team and RDSL MRA team in relation to change of RDSZ C4C products.
- Support RDSZ organization as China local manufacturer to respond to Authority inquiry or to resolve Authority issue in relation to regulatory regulation
Main Tasks & Responsibilities:
1. Support RDSL MRA to plan RDSZ C4C product registration in China.
2. Draft or review the registration related documents
3. Plan, lead and executive type testing according to the registration plan, like internal preparation, coordination and supporting QC department to executive the on-site testing, and application by the authorities.
4. Tracking, collection and review registration documents incl. type testing report according to RDSL MRA registration plan. Compile and deliver RDSL MRA team the submission binder (RDSZ part)
5. Coordinate the signature stamp and chop for the submission dossier
6. Cooperate with RDSL MRA team to support RDSZ Quality team the on-site inspection
7. Coordinate RDSZ related functions to supplement the registration/notification dossiers during technical review period per the requirement from RDSL MRA
8. Registration/notification documents archiving which include hard copy of initial submission dossiers, acceptance letter, supplementary dossiers and product registration/notification certificate and attachment of it
9. Cooperate with RDSL MRA team to support RDSZ change board for change evaluation of RDSZ C4C products. Support RDSL MRA team to perform possible regulatory actions caused by change.
10. Apply other non-product registration related certificate/license, like export certificate, drug importation license etc.
Qualification & Requirement:
Education:
- Bachelor, major in biochemistry, immunology, molecular biology, etc., master degree is a plus
Experience:
- Have solid working experiences in registration for 5 years+
- Familiar with IVD registration (Class I - III) in China Experience with audits. Knowledge on domestic IVD registration (Class I - III) in China is preferred.
Professional Competency:
- Know-how of the common processes in production, QM, QC and R&D within IVD manufacturing in China.
- Good communication skill
Roche is an equal opportunity employer.
