Regulatory Affairs Associate II

Round Lake, Illinois

Type: Contract

Category: Scientific & Clinical

Job ID: 224430

Date Posted: 07/27/2021

Location: 100% onsite in Round Lake, IL

Remote: Will accommodate remote capabilities at least a few days a week

Under general supervision, primarily responsible for the coordination and the preparation of Global Labeling Requirements, secondarily responsible for the global coordination and preparation of some documents/packages for regulatory submissions.

Essential Duties and Responsibilities:

Maintain awareness of regulatory requirements and ensure continued learning.  Assist in preparation and review of labeling, and other departmental documents.  Duties include effectively perform gap analysis across multiple products and projects-including high volume tasks requiring global consistency. Support and document sound regulatory decisions and justifications.  Compile under supervision regulatory documents for submission. Track status and progress of regulatory documentation.  Understand Regulatory Affairs' position in small project teams. Assist with Regulatory Team with daily operations as needed.  Maintain regulatory files in a format consistent with requirements. Participate as an active team member of project teams as required. Edit and proofread regulatory documentation.