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500强药企ra supervisor in Beijing

Beijing, Beijing
job type
CNY 10,000 每年
reference number
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job description

Major Accountabilities

1.         Provide regulatory inputs in new project development strategy discussion;

2.        Coordinate both local and global team on registration planning;

3.         Be accountable on the implementation the decided project registration strategy by projects planning and tracking  

4.        Be accountable on achieving the target timeline of submission and approval;

5.        Be accountable on the communication with HAs to properly address the concerns on projects; and the coordination on related HA meetings;

6.        Be accountable on the communication with Global team on the related regulatory issues on the responsible projects. 

7.         Review/approve of promotional materials and press releases for NP4 Managerial (MCC review);

8.        Contribute to optimize DRA internal operational procedures whenever is needed;

9.        Be accountable to provide regulatory support to other functional team;

10.     Be accountable for ensuring regulatory compliance for the responsible brands, registration master file and timely update in DRAGON;

11.        Ensure regulatory activities comply with company internal Code of Conduct and SOPs/WIs during routine work;

12.       Monitor regulatory changes and report to department head timely;

13.     Provide/Assist department head to coach the junior levels ;

14.     Other appointed tasks;

Ideal Background

1.         Bachelor or above with Pharmaceutical/Medical background;

2.        Fluency in English and Chinese (oral and written);

3.         At least 3 years above in RA field in international pharma-ceutical or biological industries. in RA field;

4.        The experience in filing local CTA or global CTA;

5.        The experience in fling and obtaining NDA/new indication approval;

6.        The experience in supplementary registrations to Has;

7.         The experience in oncology product submission is a plus.






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