Job Description
Please refer to the below details.
Successfully meet/ complete training milestones relevant to the position held.
Familiarity with FDA, GCPs, ICH guidelines, Life Sciences & Pharmaceutical industry
Familiarity of health authority procedures / guidance regarding electronic submissions
Perform submission publishing, assembly, and distribution activities within the specified training period
Notifying relevant stakeholders that the file is ready for approval
Multi-skilled on all allocated submissions within the team
Adapting and willing to multi-skill and assisting in other submission/task within the team
A high level of independent judgment/action in problem solving
Keeping Team Leader informed of non-routine issues, making recommendations to resolve these issues
Self-Development and Take Responsibilities for the same
Active involvement in projects and quality/change initiatives
By continually upgrading do...