- Title: Regulatory Affairs Associate
- Code: RCI-6792/6793/6795/6796
- Location: North Chicago Illinois (IL) 60064
- Posted Date: 11/06/2019
- Duration: 12 Months
Talk to our Recruiter
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Local Candidates only
- The Regulatory Information Data Coordinator assesses incoming global regulatory information for entry into client`s Registration and Documentation Management systems.
- They interact with all areas of regulatory affairs and affiliates to ensure registration management information is current, accurate, and available in regulatory systems.
- They execute established business processes and may assist in development and implementation of process/system changes and/or data remediation projects.
- They troubleshoot errors and system performance issues and work with their supervisor and IT on business problem resolution and enhancements.
- They participate and contribute in group, department and cross-functional meetings and may assist in training junior team members.
- Associate's Degree
- 2+ years in a related area including manufacturing, regulatory affairs, R&D, or quality in the pharmaceutical, medical device, or other healthcare industry.
- Experience/understanding/use of software tools.
- Demonstrated analytical and communication skills.
- Skills and knowledge of drug submissions
Top skills/experience the manager is looking for
- Any kind of regulatory experience
- Documentation processing
- Analytical skills, make sure the information is clean and accurate
- Computer savvy – this group spends all their time processing regulatory submissions and is in front of a PC all day working in several programs
- Manger isn’t looking for someone that comes from a lab, wants someone they can processing documents, especially regulatory submission processing.
- The contractor will work in two main systems, Edocs (document repository) and Tracts (internal system for internal employees to review such documents).
- The contractor should be analytical and very attentive to detail to catch errors and/or locate data within documents.
- Submittals come into the team from client`s Affiliates and involve sending them to outside regulatory bodies.
- Role is typically 8-5pm Mon-Fri with some flex to come in earlier or later.
- One day work from home is possible depending on performance as it is a privilege.