Regulatory Affairs Associate

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.
• Interested or know someone who would be a great fit? Reach out today.