Regulatory Affairs Specialist jobs in Racine, WI

Description:

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.

Skills:

Regulatory Affairs, FDA, Regulatory Submissions, IND, NDA, 510K, Pharmaceutical, Medical Device, Quality Assurance

Top Skills Details:

Regulatory Affairs,FDA,Regulatory Submissions

Additional Skills & Qualifications:

BS Degree with 2-4 Years of related Regulatory Affairs experience US FDA Experience with Veeva Vault systems is preferred.

Experience Level:

Intermediate Level

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