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ManagerFull-timeGoAI
Salary Range
$132,000 - $150,000 /year
About the Role
We are seeking a Manager of Regulatory Operations to oversee the preparation, quality control, publishing, dispatch, and archival of all regulatory submissions within the Veeva RIM system. This role ensures compliance with regulations, SOPs, and internal standards while supporting regulatory staff in coordinating electronic filings across various domains.
Key Responsibilities
- →Manage coordination and publishing of submissions to regulatory Health Authorities in eCTD format using Veeva RIM
- →Monitor submission timelines and proactively identify risks or delays using Veeva RIM dashboards
- →Provide training and guidance to regulatory staff on Veeva RIM functionality and best practices
- →Implement and optimize Veeva RIM workflows to streamline submission processes
- →Maintain accurate, audit-ready records and metadata within Veeva RIM for compliance
- →Support regulatory staff by processing submission objects and content plans with proper formatting
- →Archive regulatory submissions and correspondences; process submission metrics and reports
- →Collaborate with QA, IT, and third parties to ensure system configurations meet regulatory needs
- →Maintain regulatory chronologies and trackers as needed
- →Stay current with emerging regulations and standards related to electronic submissions
- →Develop standard operational procedures and work instructions to ensure regulatory compliance
- →Coordinate with external partners for operational deliverables including publishing support
- →Manage and resolve publishing-related issues during validation
- →Maintain regulatory submission tracking reports for CRB and MRB
- →Maintain clinical trial regulatory compliance tracking for development programs
- →Establish and maintain regulatory archive in eTMF Veeva Vault structure
- →Support a work environment focused on quality, learning, and collaboration
Requirements
- ✓Bachelor's degree in Pharmaceutical, Biological or related field (Master's preferred)
- ✓Minimum 4+ years in biopharmaceutical/biotech industry with 3+ years in publishing regulatory submissions
- ✓Strong hands-on experience with Veeva RIM systems
- ✓Proven expertise in electronic submission processes (eCTD) and global regulatory requirements
- ✓Experience with eCTD publishing tools and domestic/global submission gateways
- ✓Knowledge of best practices in Veeva RIM, Veeva PromoMats, Veeva eTMF, MS Word, Excel, and Adobe Acrobat
- ✓Ability to multi-task effectively and work under tight deadlines with excellent organizational skills
- ✓Excellent communication and interpersonal skills with self-motivation and eagerness to learn
- ✓Ability to interpret and implement complex regulatory legislation and updates
- ✓Flexibility, integrity, good judgment, and decision-making skills
- ✓Action- and results-oriented with collaborative and team-oriented approach
- ✓Occasional travel required as needed
- ✓Ability to communicate effectively and perform office-related tasks including keyboard use
