Danaher Corporation Regulatory Affairs Specialist in Beijing, China
In this role, you will independently be responsible for product registration on time according to the priority of products defined by the executive team of the company.
ESSENTIAL JOB RESPONSIBILITIES:
Be responsible for working with a cross functional team on the registration dossier preparation and submission based on product launch planning and NMPA requirement.
Be responsible for registration test protocol preparation and work closely with testing lab to perform the registration test based on registration planning and authority requirements.
Assesses changes in existing products and perform change registrations accordingly.
Develops plan for timely renewal registrations to ensure continued product supply.
Communicate closely with the Headquarters on the needs and problems of registration documentation and registration test.
Follow up closely with CMDE and NIFDC, and report the progress of product registration.
Build good network with relevant governments such as NMPA, NIFDC, and testing labs.
Follow up closely with NMPA regulation related to registration.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor’s degree of Medicine, Biology or Pharmaceutical related major, prefer to Molecular biology.
1-2 years working experience on medical, preferably on IVD registration.
Knowledge and skills:
- Skill of performing testing in lab. Experience on R&D or Lab testing work is preferred.
Good English & communication skills.
Ability and willingness to learn knowledge in related fields.
Self-motivated and able to work independently in new developmental area
Knowledge of NMPA guidelines.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.