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Senior Regulatory Affairs Specialist

Location: Beijing, China
Position Type: Fixed-Term
Job Function: Regulatory Affairs

1 Primary Purpose and Overall Objective of the Job (to be defined in only one sentence):
· Responsible for biomerieux products registration with regular time frame.

Contact with authorities (SFDA, NICPBP) & hospitals, P.R. China for each key milestone progress, including QC test, Clinical Trial, registration submission, CMDE Q&A, panel meeting, follow up and consultation.

2 Main Accountabilities:
· Make strategic and tactic plan for each high priority registration project to deliver commitment.

· In-depth regulation study and response HQ’s questions within requested answer date.

· Improve knowledge on QC test. Good relationship with NICPBP and other test institutes.

· Improve knowledge on Clinical Trial to sure the correct direction via the selection of predicate in China, early and sufficient communication with HQ Med. For CT protocol, good CT operation in hospital, timely trouble shoots.

· Familiar with BMC portfolio, and know the resource both technical and guanxi.

· Organize SFDA / CMDE panel meeting with well preparation.

· Monitor the change, trend and new standard of Chinese panel and related regulation, inform HQ and timely set up dialogue channel if needed.

· Well organized for huge registration document archive.

· Support RA head on special project.




3 Typical Studies-Experience, Skills and Qualifications:

3.1 Studies-Experience:

- Bachelor degree or above of medicine, biology & pharmacy

- At least 5-year experience in registration field in medical industry (IVD preferred)

3.2 Skills and Qualifications:

- Good command of both oral and written English

- Regular product registration

- Technical support on RA high priority project as well as the meeting with authority

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