This contractor will be working REMOTELY to help with coordinating regulatory activities, including planning, drafting, and reviewing of documents necessary to support regulatory submissions. This includes INDs, BLAs, meeting requests, briefing packages, and responses to queries from regulatory agencies.
They'll also be responsible for preparation, submission, tracking and archival of electronic submissions.
Will also be communicating and coordinating with relevant functional groups and project team members to identify and ensure the preparation of required documentation and data needed for regulatory submissions.
Will act as regulatory representative on internal project teams to ensure that development activities support and comply with the relevant regulatory requirements.
- Experience Authoring INDs and BLAs (modules 3,4,5)
- Experience with publishing submissions in eCTD systems
- Experience communicating with high level executives professionally and efficiently
Nice to Haves:
- Vaccine experience
- Phase 3 experience