Regulatory Affairs Ops Specialist - Round Lake, United States - Viva USA, Inc.

Description

Title: Regulatory Affairs Ops Specialist - Hybrid

Description:

Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types

Creating timelines for regulatory filings

Providing and maintain templates for authoring.

Overseeing authoring and reviewing of regulatory documents

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.

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

Notes:

Hybrid - 3 days onsite, 2 remote