Global Regulatory Data & Submissions Associate

Katalyst CRO; North Chicago (IL); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory Data Management

Written communication

Verbal communication

Attention to detail

Formazione

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

Strumenti

Veeva Systems

Descrizione del lavoro

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.