Job Description

Regulatory Affairs Associate I

Location: North Chicago, Illinois 60064

Duration: 11-Month Contract

Work Type: Hybrid (Onsite Tuesday, Wednesday, Thursday)

Job Summary: The Regulatory Affairs Associate I supports regulatory information management activities within a pharmaceutical and healthcare environment. This role is responsible for maintaining regulatory data accuracy, supporting compliance initiatives, managing regulatory records, and assisting with system enhancements and data migration activities. The position works closely with regulatory teams to ensure data integrity and regulatory documentation compliance.

Key Responsibilities:

• Monitor regulatory information management systems for assigned products and activities, ensuring data completeness, accuracy, and compliance.
• Create, update, and maintain product, application, registration, and regulatory records according to established data standards.
• Record and update regulatory commitments, obligations, approvals, and registration information.
• Ensure regulatory submissions are properly archived and documented within designated systems.
• Monitor and manage regulatory correspondence, agency responses, approval documentation, and related activity records.
• Update activity statuses and maintain accurate timelines within regulatory information management platforms.
• Support audit and inspection requests by providing accurate regulatory data and documentation.
• Assist with system enhancements, data remediation initiatives, and continuous process improvement activities.
• Support data migration, harmonization, and integration efforts during system upgrades, business acquisitions, and process transformations.
• Collaborate with cross-functional teams to maintain regulatory compliance and data quality standards.

Required Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, Medical Technology, Pharmacology, or a related discipline.
• Experience in the pharmaceutical, medical device, biotechnology, healthcare, or related industry.
• Strong attention to detail with the ability to manage and maintain complex regulatory data.
• Excellent verbal and written communication skills.
• Proficiency with MS Office applications.
• Ability to work effectively in a collaborative team environment.

Preferred Qualifications:

• Experience supporting Regulatory Affairs or Regulatory Operations functions.
• Exposure to Regulatory Information Management systems.
• Knowledge of regulatory documentation and submission processes.
• Experience with data migration, data remediation, or system enhancement projects.
• Understanding of regulatory compliance requirements within the healthcare or life sciences 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 off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.

Pay Range: $25/hr to $30/hr

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