Regulatory Affairs Associate
Katalyst CRO
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. #J-18808-Ljbffr Katalyst CRO
Vacancy posted 3 days ago
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