Jobs in Irvine, CA

About the role

The Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities. At Tarsus, we understand the importance of attracting and retaining top talent. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot .

What you'll bring

• Bachelor’s degree in science or health-related discipline or equivalent experience.
• Minimum of 5+ years of Regulatory Affairs Operations Experience, with a focus on publishing and/or submissions management, records management.
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards.
• Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
• Under the guidance of the Director, knowledgeable resource for regulatory advice in developing submission content plans, with hands-on responsibility for regulatory document management.
• Experience working with Veeva Regulatory Information Management System Vault is required
• administrator experience/management of Veeva RIMS is a requirement.
• Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to RA operational activities.
• Demonstrated ability to contribute to a continuous learning and process improvement.
• Strong analytical skills, good attention to detail.
• Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
• Ability to work independently as needed with minimal supervision.

Benefits