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Regulatory Affairs Manager

 

Your role:

1. To be responsible for regulatory strategies development for responsible products

 

2. To give regulatory comments for all activities of related products

 

3. To communicate with global RA, CMC and manufacturing colleagues to explain Chinese regulation, requirement and RA plans

 

4. To communicate with authorities to achieve registration objectives

 

5. To evaluate dossiers provided by global related functions and prepare regulatory dossiers for submission

 

6  To work together with logistic colleagues to prepare products registration plan to make sure there is no out of stock situation happened.

 

7  To participate RA related organization to share RA voice in these organizations.

 

8.  To support associate regulatory affair director in some RA related activities in the company

 

Reporting line: report to associate regulatory affair director of fertility product group.

 

Who you are:

 

Education: Bachelor degree or above, pharmaceutical or related subject

 

Language: Fluent in English reading, writing and speaking

 

Working experience: more than 8 years regulatory affairs experience in medical device companies. (Or more than 5 years RA experience in medical device plus more than 3 years in pharmaceutical company). MNC RA experiences will be appreciate.

 

HR95598

Functional area: Regulatory and Medical Affairs.

 

Job Requisition ID:  187034
Location:  Beijing - all
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Job Segment: Medical, Pharmaceutical, Manager, Medical Device, Healthcare, Science, Management

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