Regulatory Submission Specialist

Due to our ongoing global expansion, we have a great opportunity for aRegulatory Submissions Specialist to join our growing regulatory team in Taiwan, on a fully remote basis.

We are looking for someone who can autonomously carry on the work within the scope of their activities and interacts with the Direct Manager to define priorities and manages workload. The Regulatory Submissions Specialist contributes to the management and development of procedures related to the activities in which he/she is involved in and ensures that the outputs of their activities meet the quality standards required by the company. Ensures the timely compilation of activity tracking and attendance systems.

What you’ll do:

• Develops and maintains knowledge of global and local regulatory requirements and industry practice/guidelines for submission activities.
• Manages adaptation of master documentation for submission (Informed Consent and any additional patient i...