Senior Associate, Regulatory Affairs



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Key Accountabilities
1. Provide technical support to team members of Regulatory Affairs Department to ensure that they have the required knowledge to fulfill their duties, including training.
2. Participate in and contribute to project bids, including client presentations.
3. Support the feasibility evaluation process from Regulatory Point of View.
4. Regulatory consultation
5. Regulatory compliance review/evaluation and gap analysis, including label, common technical documents, study report, and etc.
6. Regulatory information collection and sharing
7. Regulatory submission and coordination, including initial submission, supplementary submission, amendment application and etc.
8. Archiving documents management if designated as an archivist
If designated as clinical trial submission coordinator
May be to perform the role of a Regulatory Lead in certain projects. When acting as a Regulatory Lead, the responsibilities will include the following in addition (project specific):
9. Provide the instruction to team for preparing the submission-required documents
10. Cooperate with Clinical Lead and project team to set-up submission timeline and ensure the timeline is achieved as scheduled.
11. Highlight common issues and address these with the team as a training need.
12. Raise concerns with the Project Manager/Clinical Lead as appropriate

at least having 5years RA experience
Additional Information
Location | | | Seoul Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013

Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided


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