Regulatory Affairs Associate

Katalyst CRO; North Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Information Management specialist to support regional RIM activities and maintain regulatory records using COSMOS, HUBBLE, and CIU. You will work with global teams to ensure accurate submissions and ongoing compliance across markets.

The role emphasizes data integrity, audit readiness, and cross-functional collaboration, with exposure to global regulatory processes and lifecycle management of registrations and approvals.

Qualifications

• Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or related discipline.
• Experience or exposure to Regulatory Data Management.
• Familiarity with Veeva systems.
• Strong written and verbal communication skills.
• High attention to detail and an interest in global regulatory processes.

Responsibilities

• Support regional RIM activities using COSMOS, HUBBLE, and CIU.
• Create and maintain regulatory records: product registrations, approvals, renewals, labeling changes.
• Partner with global and regional teams to align submissions and correspondence across markets.
• Monitor submission and approval activities to maintain data integrity and compliance.
• Participate in monthly quality control reviews and support remediation.
• Assist with system enhancements, upgrades, and continuous process improvement initiatives.

Skills

Regulatory Data Management

Written communication

Verbal communication

Attention to detail

Education

Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline

Tools

Veeva Systems

Job description

• Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU
• Create and maintain regulatory records, including:
• Product registrations
• Approval and renewal updates
• Indication and packaging changes
• Commitment and obligation tracking
• Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
• Monitor submission and approval activities to maintain data integrity and compliance.
• Support audit and inspection requests related to regulatory submissions and approvals.
• Participate in monthly quality control reviews, identify data gaps, and support remediation efforts.
• Assist with system enhancements, upgrades, and continuous process improvement initiatives.

Responsibilities

• Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU
• Create and maintain regulatory records, including:
• Product registrations
• Approval and renewal updates
• Indication and packaging changes
• Commitment and obligation tracking
• Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
• Monitor submission and approval activities to maintain data integrity and compliance.
• Support audit and inspection requests related to regulatory submissions and approvals.
• Participate in monthly quality control reviews, identify data gaps, and support remediation efforts.
• Assist with system enhancements, upgrades, and continuous process improvement initiatives.

Requirements:

• Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline
• Experience or exposure to Regulatory Data Management
• Familiarity with Veeva systems
• Strong written and verbal communication skills
• High attention to detail and an interest in global regulatory processes
• Why This Opportunity Stands Out
• Whether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment.