A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
Hi there, This is Siddhi, Talent Expert with Collabera LLC. Hope this message finds you well! We're hiring for Top performers encouraged to apply positions are filling fast! If interested, Let's connect and don't miss out apply today and let's talk about your next big opportunity!
Email:
siddhi.kadakia@collabera.com |
Phone:
(847)-440-1112.
Position Details:
Client Industry:
Pharmaceutical/Medical Device/Biotechnology;
Job Title:
Regulatory Affairs Associate/Specialist/Data Analyst I Location:
North Chicago, IL 60064 (Hybrid; onsite Mon-Thu, remote Friday)
Duration:
3 months Contract role
Interview Process:
1 virtual round (possible 2nd round if needed)
Pay Range:
$30.00 to $35 per hour
Key Hiring:
This is not a traditional Data Analyst role. The primary responsibility is reviewing and categorizing Health Authority RFIs (Requests for Information) from FDA, Health Canada, and
EMA/EMEA.
Candidates will review 900+ RFIs, categorize them using predefined criteria, and document findings in Excel. The focus is on understanding regulatory content rather than performing complex analytics.
Must-Have Requirements:
Pharmaceutical industry experience. Strong Regulatory Affairs / Regulatory Operations background. Experience working with health authority communications, submissions, RFIs, or regulatory documentation. Advanced Excel skills. Strong attention to detail and ability to work independently.
Preferred Backgrounds:
Regulatory Affairs Associate/Specialist Regulatory Operations Specialist Regulatory Submission Coordinator Regulatory Compliance Analyst Quality Compliance Specialist with health authority exposure
Additional Notes:
Candidates outside the area may be considered if they can relocate at their own expense and start within a reasonable timeframe. Core working hours are 9:00 AM - 3:00 PM, with some schedule flexibility outside those hours. Candidates from Regulatory Affairs, Regulatory Operations, Submission Management, and Compliance backgrounds within the pharmaceutical industry.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - These all are subject to applicable eligibility).
