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 related 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 act 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 Functional 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 and strategically guide/assist project team to resolve the issues.
12. Raise concerns with the Functional Lead as appropriate.