Regulatory Systems Manager

Ardelyx•Newark, CA

7d•Onsite

About The Position

The Regulatory Systems Manager is responsible for the administration, optimization, and day-to-day management of regulatory systems that support global regulatory operations. This role will ensure regulatory information and documentation are maintained accurately and efficiently across systems that support regulatory submissions, health authority interactions, and product lifecycle management. This position is hands-on working closely with Regulatory Affairs, Quality, and IT teams. The Regulatory Systems Manager will play a key role in improving processes, ensuring data integrity, supporting system implementations, configuration, or upgrades, and enabling efficient regulatory submissions and compliance.

Requirements

Bachelor’s degree in regulatory affairs, information systems, or related field with 5+ years of experience in regulatory operations or regulatory systems, or equivalent experience within the pharmaceutical, biotech, or life sciences industry.
Experience administering and/or supporting regulatory systems such as Veeva Vault RIM, particularly Registrations and regulatory data management, or submission publishing tools
Experience supporting global regulatory submissions and product registration tracking
Strong understanding of regulatory operations and regulatory document lifecycle
Experience working in GxP regulated environments
Strong attention to detail with focus on data integrity and compliance
Excellent organizational, communication, and cross-functional collaboration skills

Nice To Haves

Experience supporting system implementations, configuration, or upgrades is preferred
Certification or training in Veeva Vault platform

Responsibilities

Serve as the primary business owner and administrator for regulatory systems (e.g. regulatory information management systems, document management systems, and submission publishing tools)
Manage system configuration, user access, permissions, workflows, and data governance to ensure accurate and compliant regulatory records
Oversee system upgrades, releases, validation activities, and change control processes, including maintaining regulatory product data, submission data, and health authority correspondence within systems
Develop and maintain standard operating procedures (SOPs), system documentation, and training materials
Support the preparation and management of global regulatory submissions by ensuring systems and document structures align with submission requirements
Partner with Regulatory Affairs teams to track global regulatory commitments, submissions, approvals, and lifecycle activities
Ensure global regulatory documentation is properly archived and maintained in accordance with company policies and regulatory requirements
Provide user training and ongoing support for regulatory teams using Veeva RIM (Registrations, Submissions, or Archive modules)
Act as the point of contact for system questions, troubleshooting, and process guidance and vendor coordination
Act as the Regulatory Affairs representative in systems improvement projects with IT and external vendors, including performing system testing, validation support, and user acceptance testing (UAT)
Ensure regulatory systems operate in compliance with applicable regulatory requirements and internal policies