Regulatory Affairs Specialist
Found in: Appcast US C2 - 2 weeks ago
Title: Regulatory Affairs Ops Specialist
Duration: 12 Months
Location: Round Lake, IL, 60073
Hybrid - 3 days onsite, 2 remote
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 maintaining 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 ensure delivery of high-quality documents.
• Working closely with other members of the Regulatory team and providing support to their projects as needed.
• Maintaining archival of submissions and health authority communications in the Veeva RIM system.
• Provide regulatory representation on key meetings, including meetings with health agencies.
What do you bring:
• Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
• Strong organizational 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
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