Title: Regulatory Affairs Specialist

Location: Round Lake, IL

Duration: 12 Months

Hybrid - 3 days onsite, 2 WFH

Looking for local candidates, this is not a remote role

• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
• Creating timelines for regulatory filings
• Providing and maintaining templates for authoring.
• Overseeing authoring and reviewing of regulatory documents
• QC submission documents
• Contribute the development of process improvements and procedural documents.
• Identifying and assessing regulatory risks and risks 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 for 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 you bring:

• Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
• Strong organization skills and the ability 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 function independently as well as part of a team
• Able work on multiple projects concurrently and adapt a continuously changing environment.
• BA/BS in a scientific field and 2-4 years of proven experience