職位描述
*Job Description
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. Provide overall supervision and guidance for Regulatory Affairs
3. Support for administrative works of Regulatory Affairs
4. Participate in and contribute to project bids, including client presentations.
5. Support the feasibility evaluation process from Regulatory Point of View.
6. Regulatory consultation
7. Regulatory compliance review/evaluation and gap analysis, including label, common technical documents, study report, and etc.
8. Regulatory information collection and sharing
9. Regulatory and IRB-related submission and coordination, including initial submission, supplementary submission, amendment application and etc.
10. 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):
11. Provide the instruction to team for preparing the submission-required documents
12. Cooperate with Clinical Lead and project team to set-up submission timeline and ensure the timeline is achieved as scheduled.
13. Highlight common issues and address these with the team as a training need.
14. Raise concerns with the Project Manager/Clinical Lead as appropriate
*Job Qualifications
1. Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company; detail oriented; strong written and oral communications skills, as well as excellent interpersonal skills; motivated to work consistently in a fast-paced and rapidly changing environment.
2. Excellent interpersonal, verbal, and written communication skills, (including experience in making presentations at conferences, meetings, training sessions).
3. Team player with outstanding interpersonal, negotiation skills and organizational skills.
4. Demonstrated ability to manage and motivate direct reports.
5. Ability to role model behaviors and ethics in line with PAREXEL APEX Mission, Vision and Values.
6. Minimum three years experience in Regulatory Affairs
7 A bachelor (or above) degree BS in life sciences or pharmaceutical background or equivalent
8 Good communication in Fluent English
