Regulatory Affairs Specialist

4 weeks ago

Round Lake, United States Kelly Science, Engineering, Technology & Telecom Full time

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


Long term contract = ~1 year contract

Shift: Monday - Friday 1st

Hybrid - 3 days onsite, 2 remote

Compensation: based on experience



Responsibilities:

  • 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.


Qualifications:

  • BA/BS in a scientific field and 2-4 years of proven experience
  • 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.

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