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Regulatory Affairs Associate

Company:
Select Source International
Location:
North Chicago, IL, 60064
Posted:
November 07, 2019

Description:

Hi,

Greetings of the day!

This is Abhinav and I am a recruiter at Select Source International. Select Source International (SSI) is an IT, Health Care and Engineering Services Consulting firm that has been in business since 2000. SSI consultants have provided exceptional services at over 50 Fortune 500 companies, as well as 100’s of small and mid-size enterprises. I came across your resume on Job Board and your resume looking a good match to my client need. Below are details of the opportunity, if interested then please call me ASAP on 651-359-2084 or reply me on

Job Title: Regulatory Affairs Associate

Location: North Chicago Illinois USA 60064-1802

Duration: 12 months

Shift: 1st Shift (8-5pm Mon-Fri)

Description:

The Regulatory Information Data Coordinator assesses incoming global regulatory information for entry into AbbVie’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.

Experience:

• Associate 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

Intake Notes:

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 AbbVie Affiliates and involve sending them to outside regulatory bodies.