Job Details

  • Title: Clinical Regulatory Affairs Associate
  • Code: RCI-ABT-78303
  • Location: Lake Forest Illinois (IL) 60045
  • Posted Date: 07/16/2019
  • Duration: 4 Months
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  Job Description

  • Work experience: At least three to five years of work experience.
  • Understanding of scientific disciplines required. Understanding of FDA regulations governing INDs, NDAs, GCPs, submission processes, submission content, and specific time requirements for various submissions desired.
  • Good computer skills required.

Primary Job Description 

The individual will support registration of in vitro diagnostic assays by reviewing and approving verification study reports, package insert / labeling, Technical Files and other documents, and submitting documentation on schedule as directed 
As an individual contributor; the function of a Regulatory Affairs Associate is to provide support for regulatory processes and procedures. The individual may execute tasks and exercise influence generally at the peer level. 

Core Job Responsibilities: 
Responsible for implementing and maintaining the effectiveness of the quality system. 
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 
Core job responsibilities for this function may include: 
  • Assist in SOP development; review and initiation
  • Stay abreast of regulatory procedures and changes in regulatory climate and update department
  • Investigate regulatory history of similar products to assess approval implications 
  • Assist in monitoring and reporting project timelines 
  • Respond to regulatory information requests 
  • Monitor and utilize tracking and control systems 
  • Organize materials from preclinical and clinical studies for review and assist in review process 
  • Compile and organize materials for pre-submission reports 
  • Coordinate and assist in the preparation of submission/registration packages 
  • Coordinate registration requests and track completion 
  • Oversee quality control of regulatory documents and submissions 
  • Organize meetings with regulatory agency staff 
  • Update and maintain global product listings; facility registrations; licenses/approvals; and annual registrations 
  • Assist in the preparation of routine reports and regulatory agency communications 
  • Update and maintain paper/electronic document archival systems 
  • Prepare legal documents for import/export; registrations; tenders/bids or other purposes 
  • Assist with review of promotional items 
  • Coordinate internal audits and inspections 
  • Assist with global vigilance reporting and regulatory field actions such as recalls or corrections & removals 

Supervisory/Management Responsibilities: 
Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.

Position Accountability/Scope: 
Individuals coordinate and support technical and scientific regulatory activities; research regulations and guidance; and maintain and organize key information sources. Individual works under general supervision; receives limited supervision on standard issues; and detailed instructions on new assignments. Work is reviewed for soundness of judgment; overall adequacy and accuracy. 
Minimum Education: 
Bachelor's degree (or equivalent); Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. 
Minimum Experience/Training
This position does not require previous regulatory experience. 2+ years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.