Clinical Regulatory Affairs Associate

North Chicago, IL 60064

Post Date: 01/18/2018 Job ID: 25496 Category: Professional

Job Description:
  • Liaises with global affiliate sites to maintain up to date global labeling information in the global labeling repository (GLS)
  • Performs quality control of information entered by Analysts into the global labeling repository (GLS)
  • Performs proactive data remediation in global labeling repository (GLS) to ensure accurate and up to date labeling information is captured
  • Partners with Registration Management and Regulatory Information Services to ensure accurate current and historical representation of product registrations, withdrawals, submissions and approvals in the global labeling repository (GLS)
  • Partners with Global Submissions Operations to ensure all affiliate labeling needed for regulatory submissions is available in the global labeling repository (Pending Submissions)
  • Provides labeling process training to global affiliate sites
  • Assists to establish process and standards related to the global labeling repository (GLS)
  • Functions as subject matter expert for global labeling and related functional areas
  • Communicates global labeling regulatory requirements as it pertains to the global labeling repository (GLS), to department and other cross-functional areas
  • Participates on cross-functional and cross-divisional teams for process improvement initiatives
  • Assists in the development of labeling metrics per month utilizing Excel

Minimum Experience Required:
  • 4+ years of pharmaceutical, regulatory and labeling experience in a global regulatory environment or equivalent demonstrated knowledge strongly desired
  • 3+ years of experience with electronic document management technology or equivalent demonstrated knowledge
  • Demonstrated analytical capabilities
  • Demonstrated strong communication skills, effective presentation skills, negotiation and influencing skills
  • Consulting and Glemser xmLabeling experience is a plus

For more information, please contact our office at 877-782-3334.

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