USA - Regulatory Affairs Ops Specialist I

Hybrid - 3 days onsite, 2 remote

" Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
o Creating timelines for regulatory filings
o Providing and maintain templates for authoring.
o Overseeing authoring and reviewing of regulatory documents
o QC submission documents
" Contribute to the development of process improvements and procedural documents.
" Identifying and assessing regulatory risks and risks to timelines.
" Providing regulatory updates to the project team on different milestones.
" Working cross functionally with project management, operations, IT and other functions.
" Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
" Working closely with other members of the Regulatory team and provide support to their projects as needed.
" Maintaining archival of submissions and health authority communications in Veeva RIM system.
" Provide regulatory representation on key meetings, including meetings with health agency.
What do you bring:
" Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
" Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
" Excellent written and verbal communication and ability to collaborate across functions.
" Experience with Veeva Vault systems is preferred.
" Strong team player, self-motivated and able to function independently as well as part of a team
" Able to work on multiple projects concurrently and adapt to a continuously changing environment.
" BA/BS in a scientific field and 2-4 years of proven experience