- 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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- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
- 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
Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
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.
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.
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.