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Regulatory Affairs Specialist

$30 - $35 per hour

Collabera

Regulatory Affairs Associate/Specialist/Data Analyst IClient 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 hourKey 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/SpecialistRegulatory Operations SpecialistRegulatory Submission CoordinatorRegulatory Compliance AnalystQuality Compliance Specialist with health authority exposureAdditional 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).

Vacancy posted 1 day ago
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