Regulatory Affairs Associate I

4 weeks ago

Round Lake, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: Regulatory Affairs Associate I

Duration: 12 Months

Location: Round Lake, IL 60073 – Hybrid


Hybrid - 3 days onsite, 2 remote


• 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.

What do you bring:

• 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.

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

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