Position Overview
Independently manage projects of pipeline products and registered products, including but not limited to CTA, NDA, Renewal, Variations and related regulatory agency interactions. Achieve regulatory milestones within company determined timeline.
•Communicate with global RA and other stakeholders
•Preparing registration dossiers and responses to questions from CDE and other related agencies
•Follow up registration procedure
•Make good relationship with officials/reviewers
•Organize the preparation for CDE interactions (Pre-IND and Pre-NDA, etc.), including written consultation and panel meeting
•Get final registration permits
•Get related registration regulations knowledge and utilize in daily works
•Support manager to provide RA input on the strategic planning for all responsible products
Requirements
•At least 8 years working experience in pharma Industry
•Over 6 years' experience in RA field. Experience with ophthalmology products is preferred
•Bachelor and above in medicine, pharmacy or related disciplines
•Good computer skill in Excel, PowerPoint and Word
•Good interpersonal communication skill
•Good English skills both in spoken and written
Required Skills: Detail-Oriented, Global Communications, Pharmaceutical Regulatory Affairs, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Not Applicable
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
