Manager I, Regulatory Affairs Operations
$97,500–$136,500 year
HybridIrvine, California, United States
Job Summary
Create and maintain content plans within Veeva Vault RIM, understanding eCTD hierarchy and modules. Assist with planning, managing, and archiving submissions, regulatory authority correspondence, and dossier lifecycle management while maintaining compliance for annual reporting. Support the RA submissions team with project management activities, tasks, and tracking, and coordinate communication with external publishing vendors. Manage individual training records and complete designated required training. Develop fully functional regulatory operations team processes and systems under the guidance of the Director. Maintain proficiency in Veeva RIMS, eCTD templates, and project management tools. Work concurrently on projects with specific instructions, adapt quickly to changing requirements, and navigate uncertainty with minimal supervision.
Required Qualifications
- 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
- Experience working with Veeva Regulatory Information Management System Vault
- administrator experience/management of Veeva RIMS
- Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to RA operational activities
- Some travel may be required – up to 20%
Desired Qualifications
- Proficiency in Veeva Vault RIM
- Content Planning
- eCTD Viewers
- DXC (ISI) Toolbox
- Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel
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