Title : Regulatory Affairs Ops Specialist I
Location : Round Lake, IL Hybrid - days onsite, remote
Duration : Months
Pay Range : $ to $ on W
Managing the preparation of regulatory submissions for IND, ANDA, NDA, K, Clientrom, 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 Client 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 - years of proven experience
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