Regulatory Affairs Specialist

Kelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL.

Long term contract = ~1 year contract Shift: Monday - Friday 1stHybrid - 3 days onsite, 2 remoteCompensation: based on experience

Responsibilities:Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission typeso Creating timelines for regulatory filingso Providing and maintain templates for authoring.o Overseeing authoring and reviewing of regulatory documentso QC submission documentsContribute 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.

Qualifications:BA/BS in a scientific field and 2-4 years of proven experienceSolid 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 teamAble to work on multiple projects concurrently and adapt to a continuously changing environment.